Conditions: Children
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: yes

Brief 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.

Detailed description:
Probiotics are live microorganisms that, when administered in sufficient amounts, may improve health. A common use for probiotics is in addressing gastrointestinal issues, such as antibiotic-associated diarrhea (AAD). As an alternative to supplements, probiotics are also included as ingredients in fermented dairy products to produce functional foods, which are foods providing health benefits beyond their nutritional value. Yogurt, for example, is a fermented milk product often considered a functional food. One of the most commonly used probiotics is Bifidobacterium animalis ssp. lactis (BB-12).

Our Primary Aim in Years 1-2 is to conduct a pediatric randomized controlled study to establish the safety of BB-12 fortified yogurt in children. Our Secondary Aims are to examine the fecal microbiota of children prior to, during and following consumption of probiotics. This study will evaluate whether a well-defined, probiotic-containing yogurt can safely be used as an effective delivery vehicle for probiotics. This study is important to help advance probiotic research forward in a systematic, well-accepted manner. Our long-term goal is to create yogurt with sufficient probiotic dosages to positively impact many different aspects of childhood and adult health.

Arms:
arm 1: Probiotic, Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12), supplemented strawberry yogurt, 4 ounces taken orally for 10 days arm 2: Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Interventions: intervention 1: BB-12 supplemented strawberry yogurt intervention 2: Strawberry flavored yogurt
Intervention descriptions: intervention 1: Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days intervention 2: Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Protocol document: