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Completed

NCT Number: NCT03104036

Faecal Bacteriotherapy for Ulcerative Colitis

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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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centrum péče o zažívací trakt Vítkovická nemocnice, Ostrava - Vitkovice, Moravian-Silesian Region, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faecal bacterial transplantation

Other

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

Other names: FMT

Mesalazine 4G Enema

Drug

Standard mesalazine enema

Primary outcomes

  1. Clinical remission

    Time frame: Week 12

    Mayo score ≤ 2 with no subscore > 1

Secondary outcomes

  1. Endoscopic remission

    Time frame: Week 6 and 12

    Mayo endoscopic score = 0

  2. Clinical response

    Time frame: Week 6 and 12

    Decrease of Mayo score ≥ 2

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Collaborators

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

Registry information

Acronym: FACTU

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2017
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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