At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 472 enrolled
Drug / intervention
Lactobacillus acidophilus CL1285 and Lactobacillus casei +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy and Safety of BIO-K*+ CL-1285* in the Prevention of Antibiotic-associated Diarrhea in Adult Patients Exposed to Nosocomial Infection.
In Brief
A Phase 3 clinical trial evaluating Lactobacillus acidophilus CL1285 and Lactobacillus casei and placebo for Diarrhea and Clostridium Infections. Completed, enrolled 472 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea, Clostridium Infections
CountriesCanada
CollaboratorsJSS Medical Research Inc.
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMay 2006
Primary CompletionMar 2007
Study CompletionOct 2007
TodayJul 2026
First PostedMay 19, 2006
Enrollment StartMar 1, 2006
Primary CompletionMar 1, 2007
Study CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.1 years ago
Interventions
Lactobacillus acidophilus CL1285 and Lactobacillus caseidietary
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
placebodietary
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.