BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.

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

Conditions
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Recurrent Clostridium Difficile Infection

Intervention / Treatment
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* Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>BIO-K+ CL1285 | Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei<br>* 2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days<br>* Other names: BIO-K+ CL 1285;|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* 2 capsules of placebo (no live cells), consumed once daily for 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of recurrent Clostridium difficile infection |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of recurrent diarrhea episodes |  | 60 days | 
| Presence of gastrointestinal symptoms |  | 60 days | 
| Adverse events |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile, diarrhea