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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT002733-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
| Asociacion Benefica Prisma | OTHER |
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This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of pediatric diarrhea in Peru.
This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either:
A. Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
B. Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period |
|
| 2 | Placebo Comparator | Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Biological | Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Positive Blood Culture for L. Reuteri | To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture). | participants were followed for an average of 36 days |
| Mean Daily Temperature | Measured daily during 5 days of study product administration | 5 days of study product administration |
| Leukocyte Count on Day 5 | Measured on day 5 | |
| Serum Alanine Aminotransferase (ALT) in Female Participants | Day 5 | |
| Serum ALT in Males | Day 5 | |
| Serum Aspartate Aminotransferase (AST) in Females | Day 5 | |
| Serum AST in Males | Day 5 | |
| Blood Urea Nitrogen | Day 5 | |
| Serum Creatinine | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One PCR Positive Stool Specimen | Average of 36 day follow up period | |
| Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported | Day 0 through 6 weeks after Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
No enrollment of family members in households where any of the following are present:
Allergy to penicillin or cephalosporins
History of antibiotic use in the last 30 days
Use of probiotic products within the past 90 days
History of diarrheal illness within the past 30 days
Presence of fever or a pre-existing adverse event monitored in the study
Positive results on serum diagnostic tests for antibodies to HIV, Hepatitis B core antigen, and Hepatitis C.
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Oberhelman, MD | Tulane School of Public Health and Tropical Medicine | Principal Investigator |
| Margaret N Kosek, MD | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community of Santa Clara | Iquitos | Loreto | Peru |
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Potential subjects were inoformed of the study in community meetings in Santa Clara, Peru. Interested individuals were enrolled at the study clinic between Feb. 23, 2010 and April 2, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactobacillus Group | Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period |
| FG001 | Placebo Group | Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactobacillus Group | Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 of Participants With a Positive Blood Culture for L. Reuteri | To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture). | 2:1 randomization Lactbacillus:placebo using a randomizatin table as specified in the protocol | Posted | Number | participants | participants were followed for an average of 36 days |
|
6 months from initiation of study
AEs are scored as grade 1= mild, grade 1= moderate, grade 3 = severe, and grade 4 = life threatening based on the subject's interpretation of their symptom severity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactobacillus Reuteri Group | Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | Per protocol | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Oberhelman | Tulane University School of Public Health and Tropical Medicine | 504-988-2511 | oberhel@tulane.edu |
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| Placebo | Other | 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period |
|
| Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported | Day 0 through 6 weeks after Day 0 |
| Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported | Day 0 through 6 weeks after Day 0 |
| Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported | Day 0 through 6 weeks after Day 0 |
| Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported | Day 0 through 6 weeks after Day 0 |
| Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported | Day 0 through 6 weeks after Day 0 |
| Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported | Day 0 through 6 weeks after Day 0 |
Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Subjects With at Least One PCR Positive Stool Specimen | Posted | Number | participants | Average of 36 day follow up period |
|
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| Secondary | Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported | Posted | Number | days with symptom reported | Day 0 through 6 weeks after Day 0 | Days of observation | Days of observation |
|
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| Primary | Mean Daily Temperature | Measured daily during 5 days of study product administration | Posted | Mean | Standard Deviation | Degrees Celcius | 5 days of study product administration |
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| Primary | Leukocyte Count on Day 5 | Posted | Mean | Standard Deviation | cells per cubic millimeter | Measured on day 5 |
|
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| Primary | Serum Alanine Aminotransferase (ALT) in Female Participants | limited to females | Posted | Mean | Standard Deviation | units per liter (U/L) | Day 5 |
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| Primary | Serum ALT in Males | limited to males | Posted | Mean | Standard Deviation | units per liter (U/L) | Day 5 |
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| Primary | Serum Aspartate Aminotransferase (AST) in Females | limited to females | Posted | Mean | Standard Deviation | units per liter (U/L) | Day 5 |
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| Primary | Serum AST in Males | limited to males | Posted | Mean | Standard Deviation | units per liter (U/L) | Day 5 |
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| Primary | Blood Urea Nitrogen | Posted | Mean | Standard Deviation | mg/dl | Day 5 |
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| Primary | Serum Creatinine | Posted | Mean | Standard Deviation | mg/dl | Day 5 |
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| Secondary | Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported | Posted | Number | days with symptom reported | Day 0 through 6 weeks after Day 0 | days of observation | days of observation |
|
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|
| Secondary | Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported | Posted | Number | days with symptom reported | Day 0 through 6 weeks after Day 0 | days of observation | days of observation |
|
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| Secondary | Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported | Posted | Number | days with symptom reported | Day 0 through 6 weeks after Day 0 | days of observation | days of observation |
|
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| Secondary | Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported | Posted | Number | days with symptom reported | Day 0 through 6 weeks after Day 0 | days of observation | days of observation |
|
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| Secondary | Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported | Posted | Number | days with symptom reported | Day 0 through 6 weeks after Day 0 | days of observation | days of observation |
|
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| Secondary | Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported | Posted | Number | days with symptom reported | Day 0 through 6 weeks after Day 0 | days of observation | days of observation |
|
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|
| 0 |
| 30 |
| 27 |
| 30 |
| EG001 | Placebo Group | Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period | 0 | 15 | 13 | 15 |
| Diarrhea | Gastrointestinal disorders | Per protocol | Systematic Assessment |
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| Headache | Nervous system disorders | Per protocol | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Per protocol | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Per protocol | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Per protocol | Systematic Assessment |
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| Fever | Infections and infestations | Per protocol | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Per protocol | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Per protocol | Systematic Assessment |
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| vaginal discharge | Reproductive system and breast disorders | Per protocol | Systematic Assessment |
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| dysuria | Renal and urinary disorders | Per protocol | Systematic Assessment |
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| laceration | Injury, poisoning and procedural complications | Per protocol | Systematic Assessment |
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| Lumbar pain | Musculoskeletal and connective tissue disorders | Per protocol | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | Per protocol | Systematic Assessment |
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| sore throat | Respiratory, thoracic and mediastinal disorders | Per protocol | Systematic Assessment |
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