Beclomethasone dipropionate in microscopic colitis: Results of an exploratory open-label multicentre study (COLCO)

United European Gastroenterol J. 2019 Nov;7(9):1183-1188. doi: 10.1177/2050640619860965. Epub 2019 Jul 12.

Abstract

Background: Budesonide has been proven to be an effective treatment for microscopic colitis (MC). However, the two current commercially available preparations are released in the ileum. Beclomethasone dipropionate (Clipper®) is a synthetic corticosteroid with topical colonic release.

Objective: This study aimed to explore whether an open-label treatment with beclomethasone dipropionate is an effective treatment for MC.

Methods: Prospectively collected data of 30 patients from six centres were retrospectively analysed. All patients had a confirmed diagnosis of idiopathic MC (lymphocytic and collagenous colitis) and were symptomatic (i.e. ≥ 21 loose stools over a seven-day period). Treatment consisted of 10 mg beclomethasone daily for four weeks, followed by 5 mg daily for another four weeks. The primary end point was the proportion of patients in remission (i.e. a mean of < 3 stools/day and a mean of <1 watery stool per day) after an eight-week treatment period. Secondary end points were the proportion of patients responding to therapy at weeks 4 and 8, remission at weeks 4 and 12 and relapse at week 12. Reported adverse events were collected.

Results: Overall, at week 8, remission was achieved in 70%, and 77% of patients were responding to treatment. After four weeks of treatment, 80% were responding, and 67% were in remission. Four weeks after stopping treatment, 60% were still in remission.

Conclusion: This open-label study suggests that an eight-week course of beclomethasone could be a promising and relatively safe treatment for MC. A randomised controlled study is warranted.

Keywords: IBD; beclomethasone dipropionate; budesonide; collagenous colitis; lymphocytic colitis; microscopic colitis.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Beclomethasone / therapeutic use*
  • Colitis, Microscopic / drug therapy*
  • Female
  • Glucocorticoids / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Glucocorticoids
  • Beclomethasone