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This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
Protocol STP206-002 is designed as a multi-center, randomized, double-blind, placebo controlled dose escalation study of the safety and tolerability of two doses of STP206 versus control in four sequentially decreasing birth weight strata. The primary objective of this study is to assess the safety and tolerability of once daily dosing of two dose levels of STP206 versus control in four different birth weight strata in premature neonates. Secondary objectives of this study include assessment of fecal shedding of STP206 throughout dosing and describing the incidence of NEC, incidence of relevant clinical events (sepsis/bacteremia, feeding intolerance, morbidity/complications of prematurity) and neonatal growth progression in the STP206 and control treatment groups.
Neonates for whom informed consent is obtained and who meet eligibility criteria will be eligible to enroll in this study. All neonates enrolled will receive daily doses of blinded study treatment for between 2 and 11 weeks with the duration of dosing based upon gestational age at birth. All neonates enrolled in the study will be placed under Universal Precautions and all study personnel with subject contact are trained in appropriate neonatal intensive care unit (NICU) infection control practices. While in the NICU, neonates will be evaluated daily for signs/symptoms of NEC, feeding volumes/feeding tolerance, adverse events, and concomitant medications. Physical examinations and vital signs will be performed daily during the dosing period and at the end of dosing/NICU discharge. Growth assessments will be performed every other week while in the NICU and at the end of dosing/NICU discharge. Assessments for complications of prematurity, including retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), and bronchopulmonary dysplasia (BPD) will be performed at protocol defined timeframes. Neonates enrolled in the study will have fecal/meconium samples collected daily through 4 days following the start of dosing and weekly thereafter until NICU discharge to determine fecal shedding of STP6 and STP11. Following completion of blinded study treatment dosing, neonates will be evaluated at 1 week, 4 weeks, 3 months, and 6 months for safety and growth assessments.
Neonates will be stratified into the following four birth weights: 2000-1501g, 1500 to 1000 g, 999 to 750 g and 749 to 500 g. Each birth weight stratum will contain 2 dosing groups - a low dose STP206 group and a high dose STP206 group. Within each birth weight strata/dose level, subjects will be randomized in a 2:1 ratio to the STP206 or control group. Enrollment of neonates into study groups will occur sequentially. Enrollment into the high dose group within a birth weight stratum will not proceed until after the safety data from the low dose group is reviewed by the study independent Data Safety Monitoring Committee (DSMC). Similarly, enrollment into the next lower birth weight stratum will not proceed until the safety data from the high dose group of the prior weight stratum is reviewed by the study independent Data Safety Monitoring Committee (DSMC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STP206 | Experimental | Biological |
|
| Control | Placebo Comparator | Sterile water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STP206 | Biological | Live Biotherapeutic |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups | 30 days after the last dose of blinded study treatment |
| Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups | 30 days after the last dose of blinded study treatment |
| Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug | 30 days after last administration of study drug |
| Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug | 30 days after last administration of study drug |
| Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug | 30 days after last administration of study drug |
| Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). | Start of dosing to 6 months |
| Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups |
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Inclusion Criteria:
Exclusion Criteria:
Infants with, or at high probability for, early onset sepsis (positive blood cultures or with clinical/histological chorioamnionitis with the expectation of empirical antimicrobial therapy for ≥5 days)
Infants with persistent pulmonary hypertension of the newborn (PPHN)
Congenital or chromosomal anomalies
Congenital or acquired gastrointestinal pathology that preclude feeds soon after birth (e.g. cleft lip is not an exclusion criterion, but a duodenal atresia is)
Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care)
Other conditions of the infant which, in the opinion of the attending neonatologist, preclude participation
Positive maternal HIV status
Participation in another interventional clinical trial
For Part A of the study, the following additional exclusion criterion will apply:
Small for gestational age neonates, i.e. neonates that weigh less that the 10th percentile for their gestational age according to the Estimated Fetal Weight Percentile Chart
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Caplan, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States | ||
| Sheridan Clinical Research / Plantation General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose STP206 | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| FG001 | High Dose STP206 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2018 | Jan 30, 2020 |
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| Other |
Sterile Water |
|
Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug |
| 30 days after last administration of study drug |
| Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug | 30 days after last administration of study drug |
| Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug | 30 days after last administration of study drug |
| Growth Assessment Classification in Low-Dose Treatment Groups | Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0. | End of dosing/hospital discharge, up to 781 days |
| Growth Assessment Classification in High-Dose Treatment Groups | AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. LGA is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0. | End of dosing/hospital discharge, up to 781 days |
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). |
| Start of dosing to 6 months |
| Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). | Start of dosing to 6 months |
| Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). | Start of dosing to 6 months |
| Number of Patients With Sepsis in Low-Dose Treatment Groups | The presence of STP6 and STP11 was assessed in peripheral blood cultures. | Start of dosing to 6 months |
| Number of Patients With Sepsis in High-Dose Treatment Groups | The presence of STP6 and STP11 was assessed in peripheral blood cultures. | Start of dosing to 6 months |
| Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance. | Start of dosing to 6 months |
| Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance. | Start of dosing to 6 months |
| Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment. | Start of dosing to 6 months |
| Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment. | Start of dosing to 6 months |
| Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity. | From 5 days to 28 days |
| Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity. | From 5 days to 28 days |
| Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate = Need for < 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events. | Start of dosing to 6 months |
| Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate = Need for < 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events. | Start of dosing to 6 months |
| Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | The presence of STP6 and STP11 was assessed in fecal cultures. | Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days |
| Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | The presence of STP6 and STP11 was assessed in fecal cultures. | Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days |
| Sunrise |
| Florida |
| 33323 |
| United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62769 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| WakeMed Health and Hospitals | Raleigh | North Carolina | 27610 | United States |
| Medical University South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Tennessee | Memphis | Tennessee | 38163 | United States |
| The Medical Center of Plano | Plano | Texas | 75075 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
Biological
STP206: Live Biotherapeutic
~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu)
| FG002 | Control | Sterile water |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose STP206 | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| BG001 | High Dose STP206 | Biological STP206: Live Biotherapeutic ~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| BG002 | Control | Sterile water |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Gestational Age (weeks) | Count of Participants | Participants |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| 1-minute Apgar Score | The 1-minute Apgar score, ranging from 0 to 10, indicates how well neonates tolerate the birthing process. A higher score indicates better tolerance. Five subscales, scored from 0 to 2, are summed to obtain the total score. The neonate is assessed for activity (muscle tone), pulse, grimace, appearance (color), and respiration. | 1-minute Apgar scores were not obtained for all subjects. | Mean | Standard Deviation | units on a scale |
| ||||||||
| 5-minute Apgar Score | The 5-minute Apgar score, ranging from 0 to 10, indicates how well neonates are doing 5 minutes after birth. A higher score indicates better well being. Five subscales, scored from 0 to 2, are summed to obtain the total score. The neonate is assessed for activity (muscle tone), pulse, grimace, appearance (color), and respiration. | 5-minute Apgar scores were not obtained for all subjects. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Birth Weight | Birth weight data were not obtained for all subjects. | Mean | Standard Deviation | grams |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups | The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups | Safety population | Posted | Count of Participants | Participants | 30 days after the last dose of blinded study treatment |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups | The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups | Safety population | Posted | Count of Participants | Participants | 30 days after the last dose of blinded study treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug | Safety population | Posted | Count of Participants | Participants | 30 days after last administration of study drug |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug | Safety population | Posted | Count of Participants | Participants | 30 days after last administration of study drug |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug | Safety | Posted | Count of Participants | Participants | 30 days after last administration of study drug |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug | Safety | Posted | Count of Participants | Participants | 30 days after last administration of study drug |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups | Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug | Safety | Posted | Count of Participants | Participants | 30 days after last administration of study drug |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups | Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug | Safety | Posted | Count of Participants | Participants | 30 days after last administration of study drug |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Growth Assessment Classification in Low-Dose Treatment Groups | Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0. | Safety | Posted | Count of Participants | Participants | No | End of dosing/hospital discharge, up to 781 days |
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| Primary | Growth Assessment Classification in High-Dose Treatment Groups | AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. LGA is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0. | Safety population | Posted | Number | participants | End of dosing/hospital discharge, up to 781 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
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| Secondary | Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups | NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe). | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Sepsis in Low-Dose Treatment Groups | The presence of STP6 and STP11 was assessed in peripheral blood cultures. | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Sepsis in High-Dose Treatment Groups | The presence of STP6 and STP11 was assessed in peripheral blood cultures. | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups | Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance. | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Feeding Intolerance in High-Dose Treatment Groups | Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance. | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups | ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment. | Intent-to-Treat | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups | ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment. | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups | IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity. | Posted | Count of Participants | Participants | From 5 days to 28 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups | IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity. | Posted | Count of Participants | Participants | From 5 days to 28 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups | Mild to Moderate = Need for < 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events. | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups | Mild to Moderate = Need for < 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events. | Posted | Count of Participants | Participants | Start of dosing to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups | The presence of STP6 and STP11 was assessed in fecal cultures. | Safety population | Posted | Number | participants | Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups | The presence of STP6 and STP11 was assessed in fecal cultures. | Safety population | Posted | Number | participants | Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days |
|
6 months after last administration of study drug
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1a (Birth wt: 2000-1501 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) | 0 | 8 | 1 | 8 | 7 | 8 |
| EG001 | Group 1a (Birth wt:2000-1501 g) Control | Sterile water | 1 | 4 | 1 | 4 | 4 | 4 |
| EG002 | Group 2a (Birth wt:1500-1000 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) | 1 | 9 | 2 | 9 | 7 | 9 |
| EG003 | Group 2a (Birth wt:1500-1000 g) Control | Sterile water | 0 | 4 | 2 | 4 | 3 | 4 |
| EG004 | Group 3a (Birth wt:999-750 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) | 0 | 9 | 3 | 9 | 9 | 9 |
| EG005 | Group 3a (Birth wt:999-750 g) Control | Sterile water | 0 | 5 | 3 | 5 | 5 | 5 |
| EG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) | 2 | 8 | 5 | 8 | 8 | 8 |
| EG007 | Group 4a (Birth wt:749-500 g) Control | Sterile water | 0 | 4 | 1 | 4 | 4 | 4 |
| EG008 | Group 1b (Birth wt: 2000-1501 g) High Dose | Biological STP206: Live Biotherapeutic ~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu) | 0 | 8 | 1 | 8 | 6 | 8 |
| EG009 | Group 1b (Birth wt:2000-1501 g) Control | Sterile water | 0 | 4 | 0 | 4 | 4 | 4 |
| EG010 | Group 2b (Birth wt: 1500-1000 g) High Dose | Biological STP206: Live Biotherapeutic ~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu) | 0 | 8 | 2 | 8 | 7 | 8 |
| EG011 | Group 2b (Birth wt:1500-1000 g) Control | Sterile water | 0 | 4 | 0 | 4 | 3 | 4 |
| EG012 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu) | 0 | 8 | 2 | 8 | 7 | 8 |
| EG013 | Group 3b (Birth wt:999-750 g) Control | Sterile water | 0 | 4 | 1 | 4 | 3 | 4 |
| EG014 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~ 9 billion (9×10^9) cfu of STP6 and ~900 million (9 × 10^8) cfu of STP11 (total of 9.9 billion cfu) | 1 | 8 | 4 | 8 | 8 | 8 |
| EG015 | Group 4b (Birth wt:749-500 g) Control | Sterile water | 1 | 4 | 4 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest neonatal | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Patent ductus arterioles | Congenital, familial and genetic disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia escherichia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Near drowning | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Feeding disorder of infancy or early childhood | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest neonatal | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Foetal heart rate deceleration | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pulmonary valve stenosis | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Adrenogenital syndrome | Congenital, familial and genetic disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Craniosynostosis | Congenital, familial and genetic disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Middle ear effusion | Ear and labyrinth disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Intestinal stenosis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Neonatal pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Ophthalmia neonatorum | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia escherichia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Near drowning | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood osmolarity decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Body temperature decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood osmolarity increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Haematocrit | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Feeding disorder neonatal | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Enteral feeding intolerance | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Late metabolic acidosis of newborn | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Feeding disorder of infancy or early childhood | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Underweight | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| CNS ventriculitis | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Intraventricular haemorrhage neonatal | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gross motor delay | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypertonia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Testicular mass | Reproductive system and breast disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Apnoea neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Bronchopulmonary dyspasia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cough | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Neonatal hypoxia | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vocal cord disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pulmonary interstitial emphysema syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Rodgers, MS, CCRA, ACRP-PM / Sr Director of Clinical Operations | Leadiant Biosciences, Inc. | 301-670-1565 | scott.rodgers@leadiant.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2018 | Jan 30, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
|
| >28 |
|
|
|
|
|
|
|
| Subjects with at least one treatment-related TEAE |
|
| Subjects with at least one TEAE Grade 3 |
|
| Subjects with at least one related TEAE Grade 3 |
|
| Subjects with TEAEs leading to stopping study drug |
|
| Subjects with at least one serious adverse event |
|
| Number of deaths |
|
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 |
| Group 3a (Birth wt: 999-750 g) Low Dose |
Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 | Group 3a (Birth wt: 999-750 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 |
| Group 3a (Birth wt: 999-750 g) Low Dose |
Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 |
| Group 3b (Birth wt: 999-750 g) High Dose |
Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
| Group 2a (Birth wt: 1500-1000 g) Low Dose |
Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG003 | Group 2a (Birth wt: 1500-1000 g) Control | Sterile water |
| OG004 | Group 3a (Birth wt: 999-750 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG003 | Group 2a (Birth wt: 1500-1000 g) Control | Sterile water |
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 |
| Group 3a (Birth wt: 999-750 g) Low Dose |
Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 |
| Group 3a (Birth wt: 999-750 g) Low Dose |
Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
Sterile water
| OG004 | Group 3a (Birth wt: 999-750 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
Sterile water
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
Sterile water |
| OG004 | Group 3a (Birth wt: 999-750 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 |
| Group 3a (Birth wt: 999-750 g) Low Dose |
Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
| OG004 |
| Group 3b (Birth wt: 999-750 g) High Dose |
Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
Sterile water |
| OG004 | Group 3a (Birth wt: 999-750 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
Sterile water |
| OG004 | Group 3b (Birth wt: 999-750 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|
| Group 3a (Birth wt: 999-750 g) Low Dose |
Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG005 | Group 3a (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4a (Birth wt: 749-500 g) Low Dose | Biological STP206: Live Biotherapeutic ~1 billion (1 × 10^9) cfu of STP6 and ~100 million (1 × 10^8) cfu of STP11 (total of 1.1 billion cfu) |
| OG007 | Group 4a (Birth wt: 749-500 g) Control | Sterile water |
|
|
| Group 3b (Birth wt: 999-750 g) High Dose |
Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG005 | Group 3b (Birth wt: 999-750 g) Control | Sterile water |
| OG006 | Group 4b (Birth wt: 749-500 g) High Dose | Biological STP206: Live Biotherapeutic ~9 billion (9 × 10^9) cfu of STP6 and ~900 million (900 × 10^8) cfu of STP11 (total of 9.9 billion cfu) |
| OG007 | Group 4b (Birth wt: 749-500 g) Control | Sterile water |
|
|