Faecal Bacteriotherapy for Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mesalazine 4G Enema

Intervention Type DRUG

Standard mesalazine enema

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.

Group Type EXPERIMENTAL

Faecal bacterial transplantation

Intervention Type OTHER

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

Interventions

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Faecal bacterial transplantation

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

Intervention Type OTHER

Mesalazine 4G Enema

Standard mesalazine enema

Intervention Type DRUG

Other Intervention Names

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FMT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No