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

Bio-K Plus

Status and phase: Suspended; Phase 3

Conditions: Recurrent Clostridium Difficile Infection

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01202630

09-SUS-05-BIK-02

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

BIO-K+ CL1285

Treatment:

Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo