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Clinical Trial Summary

The purpose of this research study is to compare how well two formulations of budesonide (budesonide MMX [Cortiment] and budesonide CR [Entocort]) work for treating patients with microscopic colitis.


Clinical Trial Description

After being informed of the study and potential risks, patients with symptomatically active microscopic colitis who provide written informed consent will undergo a 4-week screening period to determine their eligibility for the study. At week 0, eligible patients will be randomized in a single blind manner (patients will be aware, while investigators will be blinded) in a 1:1 ratio to budesonide MMX (9mg once daily) or budesonide CR (3mg three times daily). The total treatment duration will be for 8 weeks. The primary outcome will be clinical remission, defined by the Hjortswang criteria (daily average <3 loose/watery bowel movements per 24 hours in the week preceding the final assessment (loose/watery stool consistency will be measured using the Bristol Stool Chart (types 6 and 7)). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05915104
Study type Interventional
Source University of Calgary
Contact Christopher Ma, MD MPH
Phone 403-592-5013
Email christopher.ma@ucalgary.ca
Status Not yet recruiting
Phase Phase 2
Start date January 1, 2024
Completion date December 31, 2026

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