BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
NCT ID: NCT01202630
Last Updated: 2016-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
140 participants
INTERVENTIONAL
2010-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Probiotic
BIO-K+ CL1285
Lactobacillus acidophilus CL1285® and Lactobacillus casei
2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days
Placebo
Placebo
Placebo
2 capsules of placebo (no live cells), consumed once daily for 60 days
Interventions
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Lactobacillus acidophilus CL1285® and Lactobacillus casei
2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days
Placebo
2 capsules of placebo (no live cells), consumed once daily for 60 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
3. Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
5. Understand the nature and purpose of the study including potential risks and side effects
6. Willing to comply with the requirements of the study
Exclusion Criteria
2. Presence of severe chronic and/or inflammatory condition
3. Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
4. Major gastrointestinal complication, e.g. Crohn's disease or ulcer
5. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
6. Use of proton pump inhibitors
7. Pregnant female or breastfeeding
8. Eating disorder
9. History of alcohol, drug, or medication abuse
10. Daily consumption of probiotics, fermented milk, and/or yogurt
11. Known allergies to any substance in the study product
12. Participation in another study with any investigational product within 3 months of screening
18 Years
ALL
No
Sponsors
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Sprim Advanced Life Sciences
OTHER
Bio-K Plus International Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cornelius J Foley, MD
Role: PRINCIPAL_INVESTIGATOR
Parker Jewish for Health Care and Rehabilitation
Locations
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Parker Jewish Institute
New Hyde Park, New York, United States
Countries
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References
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Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. Am J Gastroenterol. 2010 Jul;105(7):1636-41. doi: 10.1038/ajg.2010.11. Epub 2010 Feb 9.
Other Identifiers
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09-SUS-05-BIK-02
Identifier Type: -
Identifier Source: org_study_id
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