Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children
Condition: Children
Intervention: BB-12 supplemented strawberry yogurt; Strawberry flavored yogurt
Intervention description: 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
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion criteria for parents/caregivers are:

          1. Ability to read, speak and write English or Spanish

          2. Access to a refrigerator for proper storage of drink

          3. Telephone access

        Inclusion criteria for children are:

        1. Are between the ages of 1 and 5 years

        Exclusion Criteria:

          1. Developmental delays

          2. Any chronic condition, such as diabetes or asthma, that requires medication

          3. Prematurity, birth weight < 2,500 grams

          4. Congenital anomalies

          5. Failure to thrive

          6. Allergy to strawberry

          7. Active diarrhea (defined as three or more loose stools for two consecutive days)

          8. Any other medicines used except anti-pyretic medicines (to reduce fever) [excluding as
             needed medications]

          9. Parental belief of lactose intolerance

         10. History of heart disease, including valvulopathies or cardiac surgery, any implantable
             device or prosthetic

         11. History of gastrointestinal surgery or disease

         12. Milk-protein allergy

         13. Allergy to any component of the product or the yogurt vehicle

         14. During the baseline physical exam, have an oxygen saturation rate <96% and respiratory
             and pulse rate outside the normal range per their age.

        Parents/caregivers will also be asked to refrain from giving their child any probiotic
        foods or supplements during the entire 2 weeks of the active intervention period, and 2
        weeks before day 1 of starting the yogurt. Parents will be supplied with a list of products
        to avoid.