Last reviewed · How we verify
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics (PHASE)
We 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 our drink and comply with the FDA's recommendations pertaining to an IND application, we will conduct a phase I safety study. We hypothesize that BB-12 is safe in healthy adults ages 18 and over.
Details
| Lead sponsor | Georgetown University |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2009-10 |
| Completion | 2011-07 |
Conditions
- Adults on Antibiotics
Interventions
- Bifidobacterium animalis subsp. lactis strain BB-12
- Placebo
Primary outcomes
- The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics. — 1 year
Countries
United States