At a glance
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Yogurt Beverages as a Vehicle to Deliver High Dose Probiotics
In Brief
A Phase 1 clinical trial evaluating BB-12 supplemented strawberry yogurt and Strawberry flavored yogurt for Children. Completed, enrolled 62 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
Placebo, strawberry yogurt, 4 ounces taken orally for 10 days