Faecal Microbiota Transplantation in Patients With Microscopic Colitis (NCT03275467) | Clinical Trial Compass
CompletedNot Applicable
Faecal Microbiota Transplantation in Patients With Microscopic Colitis
Sweden10 participantsStarted 2017-06-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Signed informed consent
✓. Active MC diagnosis, defined as \>3 stools a day from which at least one should be watery
✓. Willingness to stop budesonide treatment during participation in the trial
✓. Age: 18-70 years
Exclusion criteria
✕. Previous complicated gastrointestinal surgery
✕. Malignant disease except non-melanoma skin cancer
✕. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
✕. C. difficile or other current gastroenteritis
✕. Females who are pregnant or breast-feeding
✕. Severe endometriosis
✕. Antimicrobial treatment 4 weeks prior to first screening visit
What they're measuring
1
Proportion of MC patients in remission six weeks after the first FMT.