NCT00848003

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Adults on Antibiotics

Interventions

Type	Name	Description
DRUG	Bifidobacterium animalis subsp. lactis strain BB-12	Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
DRUG	Placebo	Strawberry flavored yogurt

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-02-20
• Last updated: 2013-05-20

Locations

1 site across 1 country: United States