The value of faecal calprotectin (CPT) in monitoring the response to treatment of patients with inflammatory bowel disease

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2003
INTERVENTION: 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 µg/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 µg/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 µg/g will be compared. Updated 28/04/2015: the trial was stopped due to participant recruitment issues. CONDITION: Inflammatory bowel disease ; Digestive System ; Crohn's disease [regional enteritis] PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 80 patients
Epistemonikos ID: 6a1f314ff1c45a83825df3776a6cda36c329ac00
First added on: Aug 21, 2024