Faecal Bacteriotherapy for Ulcerative Colitis

Institute for Clinical and Experimental Medicine61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Left-sided ulcerative colitis \> 15cm ongoing more than 3 month * Mayo score \< 10 * Endoscopic Mayo score ≥ 2 Exclusion Criteria: * Anti-TNF medication in the previous 6 months * Cyclosporine in the previous 4 weeks * Methotrexate in the previous 2 months * Prednisone \> 10mg * The real risk of colectomy in the near future * Positive stool culture (Salmonella, Shigella, Yersinia, Campylobacter, pathogenic E. coli) * CMV infection * Pregnancy, breastfeeding women

Locations (9)

Gastroenterology departement Hospital České Budějovice

České Budějovice, Jihočeský kraj, Czechia

Centrum péče o zažívací trakt Vítkovická nemocnice

Ostrava - Vitkovice, Moravskoslezský kraj, Czechia

Second department of internal medicine of University Hospital Olomouc

Olomouc, Olomoucký kraj, Czechia

IV. Department of Internal Medicine, General University Hospital in Prague

Prague, Prague 2, Czechia

Internal departement of Thomayer Hospital

Prague, Prague 4, Czechia

ISCARE

Prague, Prague 7, Czechia

II. Department of Internal Medicine University Hospital Vinohrady

Prague, Czechia

Institute of clinical and experimental medicine

Prague, Czechia

Internal departement Hospital Na Bulovce

Prague, Czechia

Outcomes

Primary Outcomes

Clinical remission

Mayo score ≤ 2 with no subscore \> 1

Time frame: Week 12

Secondary Outcomes

Endoscopic remission

Mayo endoscopic score = 0

Time frame: Week 6 and 12

Clinical response

Decrease of Mayo score ≥ 2

Time frame: Week 6 and 12