Clinical Trials Logo

Clinical Trial Summary

This study examines how a fermentable dietary fibre known to promote butyrate production impacts intestinal barrier function, intestinal microbiota, intestinal inflammation, and gastrointestinal symptoms in patients with microscopic colitis.


Clinical Trial Description

The study examines the effects of a 6-week supplementation period with a dietary fibre product (type of wheat bran) on intestinal barrier function, intestinal inflammation, intestinal microbiota, and gastrointestinal symptoms in patients with MC. The study subjects will consume the study products (placebo-fibre, butyrate-promoting fibre) as a powder supplemented to their daily habitual diet. A maltodextrin-based product is used as placebo. After giving their informed consent, the study subjects fill out a background questionnaire to assess their eligibility for the study (Visit 1). Participants deemed suitable for the study will be randomised into two study arms (placebo-fibre, butyrate-promoting fibre) before undergoing a baseline visit (Visit 2) before the start of the intervention period. After the 6-week intervention period, the participants will come back for a final visit (Visit 3). In vivo intestinal permeability will be measured using the standard multi-sugar test at visits 2 and 3. Blood and faecal samples will also be collected during visits 2 and 3. In addition to the visits described above, a subset of patients (max. 20) will undergo a colonoscopy before and at the end of the intervention period at Örebro University Hospital where an experienced gastroenterologist collects 16 colonic biopsies. These colonic biopsies are mounted in an Ussing chamber system to specifically study colonic permeability. During visits 2 and 3, the participants also complete questionnaires to assess their gastrointestinal symptoms, quality of life, physical activity, and dietary habits. During the study period, the participants will also keep a daily diary recording the number of diarrheal and loose stools. The participants are asked to maintain their habitual diet and lifestyle as well as not to consume probiotic or prebiotic supplements. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05058131
Study type Interventional
Source Örebro University, Sweden
Contact Richard A Forsgård, PhD
Phone 0790614037
Email [email protected]
Status Recruiting
Phase N/A
Start date October 30, 2021
Completion date June 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT02303132 - Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis N/A
Recruiting NCT04043897 - Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis Phase 2
Recruiting NCT03477032 - FMT in Inflammatory Bowel Disease
Completed NCT03275467 - Faecal Microbiota Transplantation in Patients With Microscopic Colitis N/A
Completed NCT01928667 - Case-Control Study to Identify Risk Factors for Microscopic Colitis N/A
Completed NCT00180050 - Budesonide Treatment for Lymphocytic Colitis Phase 3
Completed NCT00952952 - Trial of Mesalamine for the Treatment of Active Microscopic Colitis Phase 2/Phase 3