MedTrace Logo

Faecal Bacteriotherapy for Ulcerative Colitis

NCT03104036 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-10-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Institute of Animal Physiology and Genetics Academy of Science Czech Republic

    collaborator UNKNOWN

  • Institute for Clinical and Experimental Medicine

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2021-01-30
Completion
2021-06-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03104036 on ClinicalTrials.gov