Faecal Microbiota Transplantation in Patients With Microscopic Colitis
- Conditions
- Microscopic Colitis
- Interventions
- Other: Faecal microbiota transfer (FMT)
- Registration Number
- NCT03275467
- Lead Sponsor
- Örebro University, Sweden
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Faecal microbiota transfer (FMT) Faecal microbiota transfer (FMT) Suspended stool from a healthy donor
- Primary Outcome Measures
Name Time Method Proportion of MC patients in remission six weeks after the first FMT. 6 weeks Remission is defined as \<3 stools per day and a mean of less than one watery stool per day.
- Secondary Outcome Measures
Name Time Method Changes in faecal and mucosal microbiota composition faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; mucosal: 6 weeks 16S rRNA-based next generation sequencing
Changes in subepithelial collagen layer 6 weeks Immunohistochemistry
Changes in gastrointestinal symptom questionnaire scores 6 weeks, 8 weeks, 12 weeks, 6 months GSRS
Changes in general health questionnaire scores 6 weeks, 8 weeks, 12 weeks, 6 months SF-36
Changes in lymphocyte infiltration 6 weeks Immunohistochemistry and flow cytometry
Changes in general health and symptom questionnaire scores 6 weeks, 8 weeks, 12 weeks, 6 months SHS
Changes in quality of life questionnaire scores 6 weeks, 8 weeks, 12 weeks, 6 months EG-5D-5L
Changes in immune cell composition of colonic biopsies 6 weeks Immunohistochemistry and flow cytometry
Changes in number and form of bowel movements 6 weeks, 8 weeks, 12 weeks, 6 months 1-week-diaries
Changes in hospital and anxiety depression scores 6 weeks, 8 weeks, 12 weeks, 6 months HADS
Trial Locations
- Locations (1)
University Hospital Örebro
🇸🇪Örebro, Örebro County, Sweden