Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

Phase 1

Completed

Conditions: Children

Interventions: Other: Strawberry flavored yogurt
Drug: BB-12 supplemented strawberry yogurt

Registration Number: NCT01652287

Lead Sponsor: Georgetown University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strawberry flavored yogurt	Strawberry flavored yogurt	Placebo, strawberry yogurt, 4 ounces taken orally for 10 days
BB-12 supplemented yogurt	BB-12 supplemented strawberry yogurt	Probiotic, Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12), supplemented strawberry yogurt, 4 ounces taken orally for 10 days

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	Days 0-180	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.

Secondary Outcome Measures