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

Phase 3

Suspended

• Conditions: Recurrent Clostridium Difficile Infection

• Registration Number: NCT01202630
• Lead Sponsor: Bio-K Plus International Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of recurrent Clostridium difficile infection	60 days

Secondary Outcome Measures

Name	Time	Method
Presence of gastrointestinal symptoms	60 days
Adverse events	60 days
Duration of recurrent diarrhea episodes	60 days

Trial Locations

Locations (1)

Parker Jewish Institute; 🇺🇸 New Hyde Park, New York, United States