BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
Phase 3
Suspended
- Conditions
- Recurrent Clostridium Difficile Infection
- Registration Number
- NCT01202630
- Lead Sponsor
- Bio-K Plus International Inc.
- Brief Summary
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- Age 18 years or older
- Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
- Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Understand the nature and purpose of the study including potential risks and side effects
- Willing to comply with the requirements of the study
Exclusion Criteria
- History of 2 or more clostridium difficile infections at any time prior to the current episode
- Presence of severe chronic and/or inflammatory condition
- Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
- Major gastrointestinal complication, e.g. Crohn's disease or ulcer
- Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- Use of proton pump inhibitors
- Pregnant female or breastfeeding
- Eating disorder
- History of alcohol, drug, or medication abuse
- Daily consumption of probiotics, fermented milk, and/or yogurt
- Known allergies to any substance in the study product
- Participation in another study with any investigational product within 3 months of screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of recurrent Clostridium difficile infection 60 days
- Secondary Outcome Measures
Name Time Method Presence of gastrointestinal symptoms 60 days Adverse events 60 days Duration of recurrent diarrhea episodes 60 days
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of Lactobacillus acidophilus CL1285® in preventing recurrent Clostridium difficile infection?
How does the combination of Lactobacillus acidophilus CL1285® and Lactobacillus casei compare to standard-of-care antibiotics in preventing C. difficile recurrence?
Are there specific gut microbiota biomarkers that predict response to probiotic interventions like BIO-K+ CL1285 in C. difficile infection?
What adverse events were observed in NCT01202630 and how do they compare to other phase 3 probiotic trials for C. difficile prevention?
What are the current clinical developments of Bio-K Plus International Inc.'s probiotic formulations for gastrointestinal infections?
Trial Locations
- Locations (1)
Parker Jewish Institute
🇺🇸New Hyde Park, New York, United States
Parker Jewish Institute🇺🇸New Hyde Park, New York, United States