Budesonide as induction therapy for incomplete microscopic colitis: A randomised, placebo-controlled multicentre trial.

ABSTRACT:

Background and aims

Incomplete microscopic colitis (MCi) is a subtype of microscopic colitis (MC). Budesonide is recommended as a first-line treatment for MC. However, randomised trials on efficacy of treatment in MCi are missing. We therefore performed a randomised, placebo-controlled trial to evaluate budesonide as induction therapy for MCi.

Methods

Patients with active MCi were randomly assigned to either budesonide 9 mg once daily or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as a mean of <3 stools/day and a mean of <1 watery stool/day in the 7 days before week 8.

Results

Due to insufficient patient recruitment, the trial was discontinued prematurely. The intention-to-treat analysis included 44

SUBMITTER: Munch A 

PROVIDER: S-EPMC8435258 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature