Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

NCT01652287 | Completed Phase 1 Results DMC

• 1 other identifier: 3U01AT003600-02S1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Composition of the Gut Microbiota

  90 days

Study Arms (2)

BB-12 supplemented yogurt

ACTIVE COMPARATOR

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

Strawberry flavored yogurt

PLACEBO COMPARATOR

Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Other: Strawberry flavored yogurt

Interventions

BB-12 supplemented strawberry yogurt DRUG

Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days

BB-12 supplemented yogurt

Strawberry flavored yogurt OTHER

Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Strawberry flavored yogurt

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ability to read, speak and write English or Spanish
• Access to a refrigerator for proper storage of drink
• Telephone access
• \. Are between the ages of 1 and 5 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead
• Penn State University: collaborator

Study Sites (1)

Georgetown University Department of Family Medicine, Research Division

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

• 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.

  PMID: 28114246 RESULT

Results Point of Contact

• Title: Director of Research Programs
• Organization: Georgetown University Medical Center, Department of Family Medicine

FamilyMedResearch@georgetown.edu

202-687-1600

Study Officials

• Daniel J Merenstein, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 30, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 22, 2024
• Results First Posted: March 13, 2017

Record last verified: 2024-02

Locations

US (1)