NCT03104036

Faecal Bacteriotherapy for Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Institute for Clinical and Experimental Medicine · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Faecal bacterial transplantation	Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline
DRUG	Mesalazine 4G Enema	Standard mesalazine enema

Timeline

• Start date: 2017-06-19
• Primary completion: 2021-01-30
• Completion: 2021-06-30
• First posted: 2017-04-07
• Last updated: 2021-10-01

Locations

9 sites across 1 country: Czechia