drugset / Trial / NCT03104036

Faecal Bacteriotherapy for Ulcerative Colitis

NCT03104036

RandomizedParallel-groupOpen-labelTreatment

Summary

The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Review of the literature on FMT suggests great potential as the treatment for UC, but two prospective controlled study that has been published yet are inconsistent. The first objective of the project is to compare the administration of FMT enema with mesalazine enema for inducing remission in patients with active left-sided UC in the form of a prospective, randomized, controlled study. The second objective is to observe changes in the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to identify the bacterial species which are responsible for the effect of the FMT.

Timeline

Start
2017-06-19
Primary completion
2021-01-30
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mesalamine Small molecule 4 g Other

Indications