Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Yogurt Beverages as a Vehicle to Deliver High Dose Probiotics

Conditions
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Children

Intervention / Treatment
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* Drug: BB-12 supplemented strawberry yogurt
* Other: Strawberry flavored yogurt


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for parents/caregivers are: Ability to read, speak and write English or Spanish Access to a refrigerator for proper storage of drink Telephone access Inclusion criteria for children are: 1. Are between the ages of 1 and 5 years Exclusion Criteria: Developmental delays Any chronic condition, such as diabetes or asthma, that requires medication Prematurity, birth weight < 2,500 grams Congenital anomalies Failure to thrive Allergy to strawberry Active diarrhea (defined as three or more loose stools for two consecutive days) Any other medicines used except anti-pyretic medicines (to reduce fever) [excluding as needed medications] Parental belief of lactose intolerance History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic History of gastrointestinal surgery or disease Milk-protein allergy Allergy to any component of the product or the yogurt vehicle 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BB-12 supplemented yogurt<br>Probiotic, Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12), supplemented strawberry yogurt, 4 ounces taken orally for 10 days | Drug: BB-12 supplemented strawberry yogurt<br>* Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days<br>|
| Placebo Comparator: Strawberry flavored yogurt<br>Placebo, strawberry yogurt, 4 ounces taken orally for 10 days | Other: Strawberry flavored yogurt<br>* Placebo, strawberry yogurt, 4 ounces taken orally for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time. | Days 0-180 |