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

This study has suspended participant recruitment.
(The site is unable to recruit patients.)
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by:
Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:
NCT01202630
First received: September 14, 2010
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Recurrent Clostridium Difficile Infection
Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei
Dietary Supplement: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bio-K Plus International Inc.:

Primary Outcome Measures:
  • Incidence of recurrent Clostridium difficile infection [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of recurrent diarrhea episodes [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Presence of gastrointestinal symptoms [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: November 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
BIO-K+ CL1285
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 Name: BIO-K+ CL 1285
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
2 capsules of placebo (no live cells), consumed once daily for 60 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202630

Locations
United States, New York
Parker Jewish Institute
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Bio-K Plus International Inc.
Sprim Advanced Life Sciences
Investigators
Principal Investigator: Cornelius J Foley, MD Parker Jewish for Health Care and Rehabilitation
  More Information

Publications:
Responsible Party: Cornelius J. Foley, MD, Parker Jewish for Health Care and Rehabilitation
ClinicalTrials.gov Identifier: NCT01202630     History of Changes
Other Study ID Numbers: 09-SUS-05-BIK-02
Study First Received: September 14, 2010
Last Updated: June 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Bio-K Plus International Inc.:
Clostridium difficile
diarrhea

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on September 22, 2014