Status:
SUSPENDED
BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
Lead Sponsor:
Bio-K Plus International Inc.
Collaborating Sponsors:
Sprim Advanced Life Sciences
Conditions:
Recurrent Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01202630
Start Date
June 1 2010
End Date
January 1 2016
Last Update
January 15 2016
Active Locations (1)
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1
Parker Jewish Institute
New Hyde Park, New York, United States, 11040