Clinical trial NCT00175292: A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Inflammatory Bowel Disease
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-15
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Prevention of severe endoscopic recurrence of Crohn's disease.
Secondary outcomes:
measure: Endoscopic recurrence at 90 days and 360 days
measure: Crohn's Disease Activity Index (CDAI)
measure: Quality of life
measure: Safety and tolerance of VSL#3
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Health Sciences Centre
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Walter Mackenzie Health Sciences Centre
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Dr. D.M. Petrunia, Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Guelph
country: Canada
facility: Surrey GI Clinic
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Kingston
country: Canada
facility: Hotel-Dieu Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital - Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Quebec City
country: Canada
facility: Hopital St-Sacrement
state: Quebec
Study officials:
affiliation: University of Alberta
name: Richard Fedorak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fedorak RN, Feagan BG, Hotte N, Leddin D, Dieleman LA, Petrunia DM, Enns R, Bitton A, Chiba N, Pare P, Rostom A, Marshall J, Depew W, Bernstein CN, Panaccione R, Aumais G, Steinhart AH, Cockeram A, Bailey RJ, Gionchetti P, Wong C, Madsen K. The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease. Clin Gastroenterol Hepatol. 2015 May;13(5):928-35.e2. doi: 10.1016/j.cgh.2014.10.031. Epub 2014 Nov 6.