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Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

NCT01652287 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-03-22

Study results available
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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

Interventions

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

OTHER

Strawberry flavored yogurt

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

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Daniel J Merenstein, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01652287 on ClinicalTrials.gov