Trial | NCT01202630  Report issue

Title

BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    140
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
Study Started
Jun 30
2010
Primary Completion
Jan 31
2016
Anticipated
Study Completion
Jan 31
2016
Anticipated
Last Update
Jan 15
2016
Estimate

Dietary Supplement 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

  • Other names: BIO-K+ CL 1285

Dietary Supplement Placebo

2 capsules of placebo (no live cells), consumed once daily for 60 days

Probiotic Experimental

BIO-K+ CL1285

Placebo Placebo Comparator

Placebo

Criteria 

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
No Results Posted