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

Sponsor
University of Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT00175292
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
120
Enrollment
17
Locations
7.1
Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Probiotic - VSL#3
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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.
Study Start Date :
Dec 1, 2003

Outcome Measures

Primary Outcome Measures

  1. Prevention of severe endoscopic recurrence of Crohn's disease. []

Secondary Outcome Measures

  1. Endoscopic recurrence at 90 days and 360 days []

  2. Crohn's Disease Activity Index (CDAI) []

  3. Quality of life []

  4. Safety and tolerance of VSL#3 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Health Sciences Centre Calgary Alberta Canada
2 Royal Alexandra Hospital Edmonton Alberta Canada
3 Walter Mackenzie Health Sciences Centre Edmonton Alberta Canada
4 St. Paul's Hospital Vancouver British Columbia Canada
5 Dr. D.M. Petrunia, Inc. Victoria British Columbia Canada
6 Health Sciences Centre Winnipeg Manitoba Canada
7 Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Canada
8 Surrey GI Clinic Guelph Ontario Canada
9 McMaster University Medical Centre Hamilton Ontario Canada
10 Hotel-Dieu Hospital Kingston Ontario Canada
11 London Health Sciences Centre London Ontario Canada
12 Ottawa Hospital - Civic Campus Ottawa Ontario Canada
13 Mount Sinai Hospital Toronto Ontario Canada
14 Hopital Maisonneuve-Rosemont Montreal Quebec Canada
15 Hospitalier de l'Universite de Montreal Montreal Quebec Canada
16 Royal Victoria Hospital Montreal Quebec Canada
17 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00175292
Other Study ID Numbers:
  • VSL-FED-01
First Posted:
Sep 15, 2005
Last Update Posted:
May 14, 2008
Last Verified:
May 1, 2008
Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Recurrence

Study Results

No Results Posted as of May 14, 2008