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NCT01652287 · ClinicalTrials.gov registry record · Phase 1
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children
A Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT01652287: Completed Phase 1 study, sponsored by Georgetown University.
NCT01652287 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01652287, a Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
The investigators believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be more appealing to both children and their parents for long term consumption than pharmaceutical-like preparations. In addition to the benefits associated with the consumption of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense food. More specifically, the rationale for this Phase I study is to determine safety of this yogurt drink and comply with FDA recommendations pertaining to an Investigational New Drug application. The investigators hypothesize that BB-12 is safe in generally healthy children ages 1-5 years.
Primary Outcome
The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.
Interventions
- DRUG BB-12 supplemented strawberry yogurt
- OTHER Strawberry flavored yogurt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01652287 record still lists
NCT01652287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which BB-12 supplemented strawberry yogurt is the first listed.
NCT01652287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01652287 about?
NCT01652287 is a clinical study titled "Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children". The investigators believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be mor...
What is the current status of trial NCT01652287?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2013-02. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01652287?
The interventions under investigation include: BB-12 supplemented strawberry yogurt (DRUG), Strawberry flavored yogurt (OTHER).
Who is sponsoring clinical trial NCT01652287?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01652287's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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