drugset / Trial / NCT00848003

Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics

NCT00848003 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2009-10
Primary completion
2011-07
Completion
2011-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bifidobacterium animalis subsp. lactis strain BB-12 Other / unclassified 4 unknown Oral

Indications

No indication recorded.