FACTU: Faecal Bacteriotherapy for Ulcerative Colitis

Sponsor

Institute for Clinical and Experimental Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03104036

Collaborator

Institute of Animal Physiology and Genetics Academy of Science Czech Republic (Other)

Enrollment

Locations

Arms

48.4

Actual Duration (Months)

6.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Other: Faecal bacterial transplantation Drug: Mesalazine 4G Enema	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be split into two branches of the study by randomization criteria (gender, imunosupresive therapy). Each branch of the study will have 25-30 patients. The first group will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. A second group of patients 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.Patients will be split into two branches of the study by randomization criteria (gender, imunosupresive therapy). Each branch of the study will have 25-30 patients. The first group will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. A second group of patients 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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Faecal Bacteriotherapy for Ulcerative Colitis

Actual Study Start Date :

Jun 19, 2017

Actual Primary Completion Date :

Jan 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mesalazine 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.	Drug: Mesalazine 4G Enema Standard mesalazine enema
Experimental: Faecal bacterial transplantation enema 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.	Other: Faecal bacterial transplantation Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline Other Names: FMT

Arm

Intervention/Treatment

Active Comparator: Mesalazine 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.

Drug: Mesalazine 4G Enema

Standard mesalazine enema

Experimental: Faecal bacterial transplantation enema

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.

Other: Faecal bacterial transplantation

Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline

Other Names:

FMT

Outcome Measures

Primary Outcome Measures

Clinical remission [Week 12]
Mayo score ≤ 2 with no subscore > 1

Secondary Outcome Measures

Endoscopic remission [Week 6 and 12]
Mayo endoscopic score = 0
Clinical response [Week 6 and 12]
Decrease of Mayo score ≥ 2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology departement Hospital České Budějovice	Ceske Budejovice	Jihočeský Kraj	Czechia	370 01
2	Centrum péče o zažívací trakt Vítkovická nemocnice	Ostrava - Vitkovice	Moravskoslezský Kraj	Czechia	703 84
3	Second department of internal medicine of University Hospital Olomouc	Olomouc	Olomoucký Kraj	Czechia	77900
4	IV. Department of Internal Medicine, General University Hospital in Prague	Prague	Prague 2	Czechia	128 08
5	Internal departement of Thomayer Hospital	Prague	Prague 4	Czechia	14059
6	ISCARE	Prague	Prague 7	Czechia	17004
7	II. Department of Internal Medicine University Hospital Vinohrady	Prague		Czechia	100 34
8	Institute of clinical and experimental medicine	Prague		Czechia	14021
9	Internal departement Hospital Na Bulovce	Prague		Czechia	150 00