Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

Yogurt Beverages as a Vehicle to Deliver High Dose Probiotics

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.

Study Overview

• Status: Completed
• Conditions: Children
• Intervention / Treatment: Drug: BB-12 supplemented strawberry yogurt; Other: Strawberry flavored yogurt

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Department of Family Medicine, Research Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Composition of the Gut Microbiota	Relative abundance of operational taxonomic units (OTU) classified at the phylum level	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Composition of the Microbial Community	The secondary aim was to evaluate the influence of BB-12®-supplemented yogurt and control yogurt on the fecal microbiota of participants and determine any changes in the composition of the microbial community.	Day 10

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: Penn State University
• Investigators: Principal Investigator: Daniel J Merenstein, MD, Georgetown University

Publications and helpful links

General Publications

• Tan TP, Ba Z, Sanders ME, D'Amico FJ, Roberts RF, Smith KH, Merenstein DJ. Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB-12-Supplemented Yogurt in Healthy Children. J Pediatr Gastroenterol Nutr. 2017 Feb;64(2):302-309. doi: 10.1097/MPG.0000000000001272.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimated): July 30, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 3U01AT003600-02S1 (U.S. NIH Grant/Contract)