Prolonging remission of ulcerative colitis with the probiotic Symprove
Research type
Research Study
Full title
A double blind, placebo controlled randomised trial to assess the efficacy of a probiotic (Symprove) to prolong clinical remission in patients with ulcerative colitis at risk of relapse
IRAS ID
183662
Contact name
Bu'Hussain Hayee
Contact email
Sponsor organisation
King's College Hospital NHS Trust
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
We recently completed a study in patients with the inflammatory bowel disease ulcerative colitis and Crohn’s disease where we assessed quality of life (QOL), clinical symptoms and intestinal inflammation before and after one months ingestion of the probiotic Symprove as compared with placebo. The probiotic had no significant effect on QOL or symptoms, but reduced intestinal inflammation significantly in ulcerative colitis. Previous studies have shown that asymptomatic patients with ulcerative colitis with significant intestinal inflammation as assessed by a faecal test (calprotectin over 250 mcg/g where normal <50) are at significant risk of clinical relapse of the disease over the next 3 months (90% sensitivity) and this offers the possibility of treatment at an asymptomatic stage in order to prevent clinical relapse of the disease. Having established that the probiotic Symprove reduces intestinal inflammation in these patients without any side effects we will assess if this reduction in inflammation is maintained in the longer term (4 months) and if it translates into prolonged clinical remission. This study will assess whether Symprove reduces the rates of clinical relapse in patients with ulcerative colitis who are at significant risk of relapse when taken over 4 months as compared with placebo (randomised clinical trial).
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/2026
Date of REC Opinion
2 Feb 2016
REC opinion
Further Information Favourable Opinion