Faecal Bacteriotherapy for Ulcerative Colitis

NCT03104036 | Completed Phase 2

• 1 other identifier: F16-27449A
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 9

Brief 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

Ulcerative Colitis

Keywords

Feacal bacterial transplantation; Left-sided ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  Mayo score ≤ 2 with no subscore \> 1

  Week 12

Secondary Outcomes (2)

• Endoscopic remission

  Week 6 and 12

• Clinical response

  Week 6 and 12

Study Arms (2)

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.

Drug: Mesalazine 4G Enema

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.

Other: Faecal bacterial transplantation

Interventions

Faecal bacterial transplantation OTHER

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

Also known as: FMT

Faecal bacterial transplantation enema

Mesalazine 4G Enema DRUG

Standard mesalazine enema

Mesalazine enema

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left-sided ulcerative colitis \> 15cm ongoing more than 3 month
• Mayo score \< 10
• Endoscopic Mayo score ≥ 2

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (9)

Gastroenterology departement Hospital České Budějovice

České Budějovice, Jihočeský kraj, 370 01, Czechia

Location

Centrum péče o zažívací trakt Vítkovická nemocnice

Ostrava - Vitkovice, Moravskoslezský kraj, 703 84, Czechia

Location

Second department of internal medicine of University Hospital Olomouc

Olomouc, Olomoucký kraj, 77900, Czechia

Location

IV. Department of Internal Medicine, General University Hospital in Prague

Prague, Prague 2, 128 08, Czechia

Location

Internal departement of Thomayer Hospital

Prague, Prague 4, 14059, Czechia

Location

ISCARE

Prague, Prague 7, 17004, Czechia

Location

II. Department of Internal Medicine University Hospital Vinohrady

Prague, 100 34, Czechia

Location

Institute of clinical and experimental medicine

Prague, 14021, Czechia

Location

Internal departement Hospital Na Bulovce

Prague, 150 00, Czechia

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine; Enema

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MUDr. (principal investigator)

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 7, 2017
• Study Start: June 19, 2017
• Primary Completion: January 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (9)