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NCT03181516 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
A Phase 2 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 255
- Enrollment target
NCT03181516 is a Phase 2 study that has completed, run by Georgetown University. The registered enrollment target is 255 participants.
The verdict
NCT03181516, a Phase 2 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 255 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Control
- BIOLOGICAL Bifidobacterium animalis subsp. lactis BB-12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2017-09-30 |
| Est. Completion | 2023-10-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03181516
The ClinicalTrials.gov registry entry for NCT03181516 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 255 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT03181516 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03181516 about?
NCT03181516 is a clinical study titled "Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics". 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 suppo...
What is the current status of trial NCT03181516?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 255 participants. The study started on 2017-09-30. Estimated completion is 2023-10-11.
What interventions are being tested in trial NCT03181516?
The interventions under investigation include: Control (OTHER), Bifidobacterium animalis subsp. lactis BB-12 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03181516?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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