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Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea

NCT01972932 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-22

No results posted yet for this study

Summary

Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI) are the most common causes of healthcare associated infectious diarrhea. In light of the results obtained in a limited number of randomized clinical trials in subjects with AAD and CDI in comparison with the widespread occurrence of these diseases, it is felt that the addition of a well-controlled clinical trial in a western environment would add value to support the use of a specific probiotic to counteract these diseases.

Conditions

  • Clostridium Difficile Infection
  • Antibiotic Associated Diarrhea

Interventions

DIETARY_SUPPLEMENT

Bio K+® 2 capsules orally (or via nasogastric tube)

Bio-K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic.

DIETARY_SUPPLEMENT

Placebo

Placebo Comparator: 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    collaborator OTHER

  • Bio-K Plus International Inc.

    lead INDUSTRY

Principal Investigators

  • Mikhael Laskine, MD · Centre hospitalier de l'Université de Montréal (CHUM)

  • Serge Carriere, MD · Bio-K+International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-11-30
Completion
2017-08-31

Countries

  • Canada

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 NCT01972932 on ClinicalTrials.gov