Trial Details

Not Recruiting
Basic Information
Clinical ID c3387
Identifier ISRCTN81965907
Trial Title The value of faecal calprotectin (CPT) in monitoring the response to treatment of patients with inflammatory bowel disease
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory bowel disease Digestive System Crohn's disease [regional enteritis]
Interventions Patients with active inflammatory bowel disease will be treated for 2 weeks according to the advice of their clinicians with either oral prednisolone 40 mg daily (ulcerative colitis or Crohn's) or enteral feeds (Crohn's disease only). Patients failing to respond clinically to the initial 2 weeks treatment will be excluded from the trial. Those who reach remission will provide a faecal specimen for analysis of CPT. If this is less than 250 mg/g they will proceed with standard continuing therapy, either tailing off the corticosteroids, or continuing with food reintroductions if on an enteral feed. Those whose CPT after 2 weeks treatment is still raised, despite clinical improvement, will be randomised either to follow corticosteroid reduction or food reintroduction as before, or alternatively to continue the original treatment of prednisolone 40 mg, or enteral feed, with weekly determinations of CPT until the CPT falls below 250 mg/g or 4 weeks have elapsed, whichever is the sooner. Patients will be followed up for 6 months with monthly determinations of faecal CPT; clinical relapse rates in those whose CPTs after the initial 2 weeks treatment were greater, or less, than 250 mg/g will be compared. Updated 28/04/2015: the trial was stopped due to participant recruitment issues.
Participant Information
Sponsor Department of Health (UK)
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -