Clinical Trials Logo

Clinical Trial Summary

Microscopic colitis (MC) is a disease with chronic inflammation of the colon that is mostly diagnosed in middle-aged or elderly women. Patients suffer from chronic watery diarrhoea, abdominal pain and weight loss. The aetiology of MC is still unknown but it is hypothesized that MC is caused by a deregulated immune response to a luminal agent in predisposed individuals, and an important role of the intestinal microbiota is suggested.

In the current proof-of-concept study, the effect of faecal microbiota transfer (FMT) in 10 MC patients will be evaluated. FMT consists in the infusion of suspended stool from a healthy donor into the intestine of a patient with the aim to restore a disturbed intestinal microbiota.


Clinical Trial Description

This will be an intervention pilot study with a 12-week and an optional 6-months follow-up period. It will be investigated if the infusion of suspended stool from healthy donors improves the symptoms of MC patients by restoring their disturbed intestinal microbiota. This procedure is known as faecal microbiota transplantation (FMT).

MC patients (n=10) will be randomised to receive FMT using stool from one of two healthy donors.

At baseline, blood samples and mucosal biopsies will be obtained from the descending colon. In addition, faecal samples will be collected and patients will complete symptom questionnaires. The first FMT will be administered by colonoscopy, FMT 2-3 by enemas. Faecal samples will be collected and questionnaires will be completed at different time points during the study. The patients will be followed-up at 6 weeks, 8 weeks, 12 weeks and 6 months after receiving FMT 1, however, the follow-up after 6 months will be optional. Additional biopsies from the descending colon and blood samples will be collected 6 weeks after the first FMT. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03275467
Study type Interventional
Source Örebro University, Sweden
Contact
Status Completed
Phase N/A
Start date June 1, 2017
Completion date October 31, 2019

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05998174 - Faecal Microbiota Transplantation for Microscopic Colitis Early Phase 1
Recruiting NCT05058131 - Modulation of Intestinal Barrier Function and Inflammation Via Butyrate-promoting Dietary Fibre N/A
Completed NCT02303132 - Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis N/A
Terminated NCT05579444 - Systems Biology of Gastrointestinal and Related Diseases
Recruiting NCT06031064 - External Validation of a Microscopic Colitis Clinical Scoring System in Patients With Chronic Watery Diarrhoea
Recruiting NCT04043897 - Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis Phase 2
Recruiting NCT06172647 - Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer
Recruiting NCT03477032 - FMT in Inflammatory Bowel Disease
Completed NCT01928667 - Case-Control Study to Identify Risk Factors for Microscopic Colitis N/A
Completed NCT00180050 - Budesonide Treatment for Lymphocytic Colitis Phase 3
Not yet recruiting NCT05915104 - Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis Phase 2
Completed NCT00952952 - Trial of Mesalamine for the Treatment of Active Microscopic Colitis Phase 2/Phase 3