Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.