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Yogurt Beverages as a Vehicle to Deliver High Dose Probiotics
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.
Details
| Lead sponsor | Georgetown University |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 62 |
| Start date | 2013-02 |
| Completion | 2014-07 |
Conditions
- Children
Interventions
- BB-12 supplemented strawberry yogurt
- Strawberry flavored yogurt
Primary outcomes
- Number of Adverse Events — Days 0-180
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.
Countries
United States