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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 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 62 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01652287
The ClinicalTrials.gov registry entry for NCT01652287 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 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 BB-12 supplemented strawberry yogurt is the first listed.
NCT01652287 reports 0 study locations.
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.
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