Faecal Bacteriotherapy for Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mesalazine 4G Enema; Other: Faecal bacterial transplantation

• Registration Number: NCT03104036
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-07
• Study Start: 2017-06-19
• Primary Completion: 2021-01-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesalazine enema	Mesalazine 4G Enema	Will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week.
Faecal bacterial transplantation enema	Faecal bacterial transplantation	Will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week.

Primary Outcome Measures

Name	Time	Method
Clinical remission	Week 12	Mayo score ≤ 2 with no subscore \> 1

Secondary Outcome Measures

Name	Time	Method
Clinical response	Week 6 and 12	Decrease of Mayo score ≥ 2
Endoscopic remission	Week 6 and 12	Mayo endoscopic score = 0

Trial Locations

Locations (9)

Gastroenterology departement Hospital České Budějovice; 🇨🇿 Ceske Budejovice, 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