Oral budesonide for maintenance treatment of collagenous colitis: a randomized, double-blind, placebo-controlled trial

Gastroenterology. 2008 Nov;135(5):1510-6. doi: 10.1053/j.gastro.2008.07.081. Epub 2008 Aug 7.


Background & aims: Oral budesonide effectively induces clinical remission in patients with collagenous colitis, a debilitating illness characterized by chronic watery/loose diarrhea, but there is a high rate of relapse after treatment cessation.

Methods: This randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of long-term therapy with oral budesonide (Entocort CIR capsules) for maintenance of clinical remission of collagenous colitis. Patients were aged >18 years with histologically proven collagenous colitis and >3 watery/loose stools per day on >or=4 of the prior 7 days. Open-label oral budesonide 9 mg/d was administered to all patients for 6 weeks. Patients in clinical remission (<or=3 stools per day) at week 6 were subsequently randomized to double-blind oral treatment with budesonide 6 mg/d or matching placebo for 6 months. Relapse was defined as >3 stools per day on >or=4 consecutive days (and included patients withdrawn because of adverse events).

Results: Of 48 enrolled patients, 46 (96%) achieved clinical remission at week 6 and were randomized to maintenance budesonide or placebo. There were 21 relapses during maintenance therapy, and almost all occurred during the first 2 months. Budesonide therapy was associated with a significantly lower cumulative rate of relapse compared with placebo (6/23 [26%] and 15/23 [65%], respectively; P = .022), and high correlation between clinical remission and histologic improvement was observed. Budesonide was well tolerated with no serious adverse events.

Conclusions: Oral budesonide 6 mg/d is efficacious and well tolerated for long-term maintenance of clinical remission in patients with collagenous colitis.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Biopsy
  • Budesonide / administration & dosage*
  • Colitis, Collagenous / diagnosis
  • Colitis, Collagenous / drug therapy*
  • Colonoscopy
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage*
  • Humans
  • Intestinal Mucosa / pathology
  • Male
  • Middle Aged
  • Quality of Life
  • Remission Induction
  • Retrospective Studies
  • Treatment Outcome


  • Glucocorticoids
  • Budesonide