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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
Health Sciences Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Dr. D.M. Petrunia, Inc.
Victoria, British Columbia, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Surrey GI Clinic
Guelph, Ontario, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
Hotel-Dieu Hospital
Kingston, Ontario, Canada
...and 7 more locations
Prevention of severe endoscopic recurrence of Crohn's disease.
Endoscopic recurrence at 90 days and 360 days
Crohn's Disease Activity Index (CDAI)
Quality of life
Safety and tolerance of VSL#3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.