Trial | NCT03104036  Report issue

Official Title

Faecal Bacteriotherapy for Ulcerative Colitis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    61
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 Started
Jun 19
2017
Primary Completion
Jan 30
2021
Study Completion
Jun 30
2021
Last Update
Oct 01
2021

Other Faecal bacterial transplantation

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

  • Other names: FMT

Drug Mesalazine 4G Enema

Standard mesalazine enema

Mesalazine enema Active Comparator

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 Experimental

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.

Criteria 

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
No Results Posted