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Mechanisms of Probiotics and Antibiotic-Associated Diarrhea

NCT04414722 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-02-25

Study results available
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Summary

The focus of the study is to better understand the mechanisms causing antibiotic-associated diarrhea (AAD) and how probiotics may prevent some of the iatrogenic effects of antibiotic medications. One of the most common indications for probiotics is for prevention of antibiotic-associated diarrhea. Clinically, different probiotic strains have demonstrated the ability to prevent AAD; however, the mechanism of action behind this effect has not been elucidated. Data from several studies suggest that antibiotic-induced disruption of commensal bacteria in the colon results in a significant (up to 50%) reduction in short chain fatty acid (SCFA) production and a concomitant reduction in Na-dependent fluid absorption resulting in AAD. Probiotics have been shown to ameliorate a variety of gastrointestinal disease states and thus, the study investigators hypothesize that administration of a probiotic yogurt will protect against the development of AAD.

Conditions

  • Antibiotic-associated Diarrhea

Interventions

DRUG

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

BIOLOGICAL

BB-12

Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt

OTHER

Control Yogurt

Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Maryland, Baltimore

    collaborator OTHER

  • Penn State University

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Daniel Merenstein, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-05-01
Completion
2023-05-01
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 NCT04414722 on ClinicalTrials.gov