Faecal Bacteriotherapy for Ulcerative Colitis

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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