NCT01202630SuspendedPhase 3
A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
Bio-K Plus International Inc.1 site in 1 country140 target enrollmentStarted: June 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Suspended
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Incidence of recurrent Clostridium difficile infection
Study Overview
Brief Summary
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Probiotic
Experimental
BIO-K+ CL1285
Intervention: Lactobacillus acidophilus CL1285® and Lactobacillus casei (Dietary Supplement)
Placebo
Placebo Comparator
Placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Incidence of recurrent Clostridium difficile infection
Time Frame: 60 days
Secondary Outcomes
- Presence of gastrointestinal symptoms(60 days)
- Duration of recurrent diarrhea episodes(60 days)
- Adverse events(60 days)
Investigators
Study Sites (1)
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