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

Recurrent Clostridium Difficile Infection Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01202630
• Other study ID #: 09-SUS-05-BIK-02
• Status: Suspended
• Phase: Phase 3
• First received: September 14, 2010
• Last updated: January 14, 2016
• Start date: June 2010
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Bio-K Plus International Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 140
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Recurrent Clostridium Difficile Infection

Intervention

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

Locations

Country	Name	City	State
United States	Parker Jewish Institute	New Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bio-K Plus International Inc.	Sprim Advanced Life Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of recurrent Clostridium difficile infection		60 days	No
Secondary	Duration of recurrent diarrhea episodes		60 days	No
Secondary	Presence of gastrointestinal symptoms		60 days	No
Secondary	Adverse events		60 days	Yes