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Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile

NCT02127814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2019-01-09

No results posted yet for this study

Summary

The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.

Conditions

  • Antibiotic-associated Diarrhea
  • Clostridium Difficile

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri

One chewable tablet of 1E8 CFU L. reuteri, once per day

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Alison L Steiber, PhD, RD, LD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-08-31
Completion
2017-12-31

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 NCT02127814 on ClinicalTrials.gov