Clinical trial NCT01202630: BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Recurrent Clostridium Difficile Infection
Keywords: Clostridium difficile
diarrhea
Lead sponsor: Bio-K Plus International Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2010-09-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: Incidence of recurrent Clostridium difficile infection
timeFrame: 60 days
Secondary outcomes:
measure: Duration of recurrent diarrhea episodes
timeFrame: 60 days
measure: Presence of gastrointestinal symptoms
timeFrame: 60 days
measure: Adverse events
timeFrame: 60 days
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Parker Jewish Institute
state: New York
Study officials:
affiliation: Parker Jewish for Health Care and Rehabilitation
name: Cornelius J Foley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.