At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 255 enrolled
Drug / intervention
BIO-K+ CL-1285® +1 moreother
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, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
In Brief
A Phase 3 clinical trial evaluating BIO-K+ CL-1285® and Placebo for Antibiotic-Associated Diarrhea and Clostridium Difficile-Associated Diarrhea. Completed, enrolled 255 participants.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsSprim Advanced Life Sciences
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
Primary CompletionMar 2009
Study CompletionApr 2009
First PostedAug 2009
TodayJul 2026
First PostedAug 13, 2009
Enrollment StartDec 1, 2008
Primary CompletionMar 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.9 years ago
Interventions
BIO-K+ CL-1285®other
A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
Placeboother
Placebo is devoid of microorganisms.