Microscopic Colitis Clinical Trial
Official title:
Faecal Microbiota Transplantation in Patients With Microscopic Colitis
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.
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.
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