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

This study has been completed.

Sponsors and Collaborators:	University of Alberta Canadian Institutes of Health Research (CIHR)
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00175292

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 III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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.

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:

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

Exclusion Criteria:

Use of perioperative steroids in tapering doses and anti-diarrheal agents
Treatment with a TNF-antagonist in the 8 weeks prior to resection
Clinically significant Crohn's disease elsewhere in the GI tract
Clinically documented short bowel syndrome
Serious disease other than Crohn's disease
Impaired liver or renal function
History of cancer with less than 2 years disease-free state
Abnormal Laboratory values
Alcohol or drug abuse
Some psychiatric conditions
Patients using other study medications
Patients who are unable to attend study visits or comply with study procedures
Positive pregnancy test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175292

Locations

Canada, Alberta
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Health Sciences Centre
Calgary, 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
London Health Sciences Centre
London, Ontario, Canada
Surrey GI Clinic
Guelph, Ontario, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
Hotel-Dieu Hospital
Kingston, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Canada, Quebec
Hopital St-Sacrement
Quebec City, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Hopital Maisonneuve-Rosemont
Montreal, 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

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

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases

Gastroenteritis
Intestinal Diseases
Recurrence

ClinicalTrials.gov processed this record on January 16, 2009