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Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated Diarrhea.

NCT03647995 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-10-26

No results posted yet for this study

Summary

The objective of this study is to determine the efficacy of probiotics containing 25Bn (billion) CFU (colony-forming unit) of Lactobacillus rhamnosus, Sacchromyces boulardii and Bifidobacterium breve in the prevention of antibiotic induced diarrhea and Clostridium difficile diarrhea.

The chosen population consists of 190 hospitalized patients taking antibiotics. Preselected and randomized patients will take probiotics once daily until 1 week after the course of antibiotic is over or a placebo with 0 CFU.

The primary outcome is to detect the occurrence of an antibiotic-associated diarrhea. The secondary outcome is to assess the presence of Clostridium difficile toxins in stool culture.

Conditions

  • Diarrhea, Clostridium Difficile

Interventions

DIETARY_SUPPLEMENT

Probiolife by Green Made (Pharma M)

A box containing 30 capsules of a dietary supplement containing 25 Bn CFU (detailed in previous sections)

OTHER

Placebo

A box containing 30 capsules containing an inactive substance with 0 Bn CFU.

Sponsors & Collaborators

  • Pharma M

    collaborator UNKNOWN

  • Yara El Helou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-02-02
Completion
2019-02-02

Countries

  • Lebanon

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 NCT03647995 on ClinicalTrials.gov