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A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00175292
First received: September 13, 2005
Last updated: May 12, 2008
Last verified: May 2008
History of Changes
  Purpose

This randomized placebo-controlled double-blind, multi-centre trial will determine the efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a 1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment, as defined by the absence of a severe endoscopic recurrence at day 90, will be offered open-label VSL#3 for an additional 9 months.


Condition Intervention Phase
Crohn's Disease
Inflammatory Bowel Disease
 Drug: Probiotic - VSL#3
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL#3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohn's Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Prevention of severe endoscopic recurrence of Crohn's disease.

Secondary Outcome Measures:
  • Endoscopic recurrence at 90 days and 360 days
  • Crohn's Disease Activity Index (CDAI)
  • Quality of life
  • Safety and tolerance of VSL#3

Estimated Enrollment: 120
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects 16 years of age or older
  2. Diagnosis of Crohn's disease
  3. Resection of ileocolonic Crohn's disease and small bowel to colonic anastomosis within 30 days of randomization
  4. Able to provide informed written consent
  5. Women of child-bearing potential with a negative serum pregnancy test, and/or use of effective contraception

Exclusion Criteria:

  1. Use of perioperative steroids in tapering doses and anti-diarrheal agents
  2. Treatment with a TNF-antagonist in the 8 weeks prior to resection
  3. Clinically significant Crohn's disease elsewhere in the GI tract
  4. Clinically documented short bowel syndrome
  5. Serious disease other than Crohn's disease
  6. Impaired liver or renal function
  7. History of cancer with less than 2 years disease-free state
  8. Abnormal Laboratory values
  9. Alcohol or drug abuse
  10. Some psychiatric conditions
  11. Patients using other study medications
  12. Patients who are unable to attend study visits or comply with study procedures
  13. Positive pregnancy test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175292

Locations
Canada, Alberta
Health Sciences Centre
Calgary, Alberta, Canada
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Dr. D.M. Petrunia, Inc.
Victoria, British Columbia, Canada
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
Surrey GI Clinic
Guelph, Ontario, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
Hotel-Dieu Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Hopital St-Sacrement
Quebec City, Quebec, Canada
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Richard Fedorak, MD University of Alberta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00175292     History of Changes
Other Study ID Numbers: VSL-FED-01
Study First Received: September 13, 2005
Last Updated: May 12, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Recurrence
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013