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Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics

NCT03181516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2025-02-21

Study results available
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Summary

Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products used for AAD are not supported by rigorous independent research, and often results in non-evidence-based usage. The overarching objective is to move research forward for the most well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented with BB-12, and to carry out longitudinal community structure and gene expression analysis of fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population receiving antibiotics. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD.

Conditions

  • Antibiotic-associated Diarrhea

Interventions

BIOLOGICAL

Bifidobacterium animalis subsp. lactis BB-12

Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

OTHER

Control

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER

  • University of Maryland, Baltimore

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Daniel Merenstein, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2023-10-11
Completion
2023-10-11
FDA Drug
Yes

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 NCT03181516 on ClinicalTrials.gov