Faecal Bacteriotherapy for Ulcerative Colitis (FACTU)

Institute for Clinical and Experimental Medicine

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Mesalazine 4G Enema; Other: Faecal bacterial transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03104036

F16-27449A

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Mesalazine enema

Active Comparator group

Description:

Will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week.

Treatment:

Drug: Mesalazine 4G Enema

Faecal bacterial transplantation enema

Experimental group

Description:

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.

Treatment:

Other: Faecal bacterial transplantation