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| Name | Class |
|---|---|
| Penn State University | OTHER |
| University of Maryland, Baltimore | OTHER |
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Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products used for AAD are not supported by rigorous independent research, and often results in non-evidence-based usage. The overarching objective is to move research forward for the most well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented with BB-12, and to carry out longitudinal community structure and gene expression analysis of fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population receiving antibiotics. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BB-12 | Experimental | Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt |
|
| Control | Placebo Comparator | Yogurt without Bifidobacterium animalis subsp. lactis BB-12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium animalis subsp. lactis BB-12 | Biological | Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Diarrhea | Diarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea. | 14 days |
| Adverse Events | Number of reported adverse events over the duration of the study | Days 0-180 |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Quality-of-life Score | The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory. Based on the PedsQL form filled out by participants, the scores were translated using the PedsQL form guidelines: 0=100, 1=75, 2=50,3=25,4=0. The raw scores of participants were averaged after translation. The lowest possible score is 0 and the highest possible score is 100. A higher score indicates a healthier lifestyle. |
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Inclusion Criteria:
The following is a list (non-exhaustive) of inclusive antibiotics:
Exclusion Criteria:
Developmental delays
Any chronic condition, such as diabetes or asthma, that requires medication
Prematurity, or born prior to 37 weeks gestation/of pregnancy
Congenital anomalies
Failure to thrive
Allergy to strawberry
Active diarrhea (diarrhea is defined in this study as three or more loose stools per day for two consecutive days)
Any other medicines used except anti-pyretic medicines (pro re nata concomitant medications are allowed)
Parental belief of lactose intolerance
History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
History of gastrointestinal surgery or disease
Milk-protein allergy
Allergy to any component of the product or the yogurt vehicle
Allergy or a hypersensitivity to the antibiotic prescribed by her/his provider
Allergy to any of the following medications:
blood oxygen saturation is less than 90% (if enrollment/baseline visit is completed in person and if the participant was prescribed antibiotics during a telemedicine visit)
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Merenstein, MD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Department of Family Medicine, Research Division | Washington D.C. | District of Columbia | 20007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BB-12 | Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt |
| FG001 | Control | Yogurt without Bifidobacterium animalis subsp. lactis BB-12 Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BB-12 | Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Some participants did not fill out their birthday so their age was not known. However, it was confirmed that they were between the ages of 3-12 years old when enrolling. |
| 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 Experiencing Diarrhea | Diarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea. | Posted | Count of Participants | Participants | 14 days |
|
180 Days
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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 | BB-12 | Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose Stools | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Merenstein | Georgetown University Medical Center | 2026872745 | djm23@georgetown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2021 | Dec 11, 2024 | Prot_SAP_000.pdf |
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| Control | Other | Yogurt without Bifidobacterium animalis subsp. lactis BB-12 |
|
| 7 days |
| Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea. | This will be a dichotomous (yes or no) outcome of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat. | 14 days |
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | There were certain participants who did not answer the question regarding sex, so their sex was unknown causing the number of participants to differ. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Health Insurance Status | Number | participants |
|
| Smoking in the Household | Count of Participants | Participants |
|
| Marital Status of Accompanying Guardian | Count of Participants | Participants |
|
| total annual income of all the family members living in the household before taxes | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Adverse Events | Number of reported adverse events over the duration of the study | Posted | Number | AE events | Days 0-180 |
|
|
|
| Secondary | Pediatric Quality-of-life Score | The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory. Based on the PedsQL form filled out by participants, the scores were translated using the PedsQL form guidelines: 0=100, 1=75, 2=50,3=25,4=0. The raw scores of participants were averaged after translation. The lowest possible score is 0 and the highest possible score is 100. A higher score indicates a healthier lifestyle. | Some participants did not fill out the PEDSQL Day 7 form. | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
|
|
| Secondary | Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea. | This will be a dichotomous (yes or no) outcome of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat. | Posted | Number | Events | 14 days |
|
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| 64 |
| 125 |
| EG001 | Control | Yogurt without Bifidobacterium animalis subsp. lactis BB-12 Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 | 0 | 130 | 0 | 130 | 69 | 130 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Runny Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lack of Appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | General disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
|
| Earache | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Fever |
|
| Flatulence |
|
| Lack of Appetite |
|
| Pain |
|
| Rash |
|
| Vomiting |
|
| Cough |
|
| Earache |
|
| Nasal Congestion |
|
| Runny nose |
|
| Sore throat |
|
| Diarrhea |
|