Recurrent Clostridium Difficile Infection Clinical Trial
Official title:
A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
Verified date | January 2016 |
Source | Bio-K Plus International Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
Status | Suspended |
Enrollment | 140 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 years or older 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: 1. History of 2 or more clostridium difficile infections at any time prior to the current episode 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Parker Jewish Institute | New Hyde Park | New York |
Lead Sponsor | Collaborator |
---|---|
Bio-K Plus International Inc. | Sprim Advanced Life Sciences |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of recurrent Clostridium difficile infection | 60 days | No | |
Secondary | Duration of recurrent diarrhea episodes | 60 days | No | |
Secondary | Presence of gastrointestinal symptoms | 60 days | No | |
Secondary | Adverse events | 60 days | Yes |
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