A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.