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

May 12, 2008 updated by: University of Alberta

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Health Sciences Centre
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada
        • Walter Mackenzie Health Sciences Centre
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
      • Victoria, British Columbia, Canada
        • Dr. D.M. Petrunia, Inc.
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Guelph, Ontario, Canada
        • Surrey GI Clinic
      • Hamilton, Ontario, Canada
        • McMaster University Medical Centre
      • Kingston, Ontario, Canada
        • Hôtel-Dieu Hospital
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Ottawa Hospital - Civic Campus
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada
        • Hospitalier de l'Universite de Montreal
      • Quebec City, Quebec, Canada
        • Hopital St-Sacrement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prevention of severe endoscopic recurrence of Crohn's disease.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Richard Fedorak, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 14, 2008

Last Update Submitted That Met QC Criteria

May 12, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSL-FED-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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