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Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients

NCT00328263 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2014-08-07

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus acidophilus CL1285 and Lactobacillus casei

One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

DIETARY_SUPPLEMENT

placebo

One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

Sponsors & Collaborators

  • JSS Medical Research Inc.

    collaborator INDUSTRY

  • Bio-K Plus International Inc.

    lead INDUSTRY

Principal Investigators

  • Joe S Dylewski, MD · St-Mary Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-03-31
Completion
2007-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT00328263 on ClinicalTrials.gov