Faecal Bacteriotherapy for Ulcerative Colitis (FACTU)

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 Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Mesalazine 4G Enema; Other: Faecal bacterial transplantation

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission	Mayo score ≤ 2 with no subscore > 1	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic remission	Mayo endoscopic score = 0	Week 6 and 12
Clinical response	Decrease of Mayo score ≥ 2	Week 6 and 12

Collaborators and Investigators

• Sponsor: Institute for Clinical and Experimental Medicine
• Collaborators: Institute of Animal Physiology and Genetics Academy of Science Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Feacal bacterial transplantation; Left-sided ulcerative colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: F16-27449A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No