Faecal Bacteriotherapy for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— FACTU  

Official title:

Faecal Bacteriotherapy for Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104036
• Other study ID #: F16-27449A
• Status: Completed
• Phase: Phase 2
• Start date: June 19, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Czechia	Gastroenterology departement Hospital Ceské Budejovice	Ceske Budejovice	Jihoceský Kraj
Czechia	Second department of internal medicine of University Hospital Olomouc	Olomouc	Olomoucký Kraj
Czechia	Centrum péce o zažívací trakt Vítkovická nemocnice	Ostrava - Vitkovice	Moravskoslezský Kraj
Czechia	II. Department of Internal Medicine University Hospital Vinohrady	Prague
Czechia	Institute of clinical and experimental medicine	Prague
Czechia	Internal departement Hospital Na Bulovce	Prague
Czechia	Internal departement of Thomayer Hospital	Prague	Prague 4
Czechia	ISCARE	Prague	Prague 7
Czechia	IV. Department of Internal Medicine, General University Hospital in Prague	Prague	Prague 2

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	Institute of Animal Physiology and Genetics Academy of Science Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission	Mayo score = 2 with no subscore > 1	Week 12
Secondary	Endoscopic remission	Mayo endoscopic score = 0	Week 6 and 12
Secondary	Clinical response	Decrease of Mayo score = 2	Week 6 and 12