Faecal Bacteriotherapy for Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 11 October 2021
• Main ID: NCT03104036
• Date of registration: 27/03/2017
• Prospective Registration: Yes
• Primary sponsor: Institute for Clinical and Experimental Medicine
• Public title: Faecal Bacteriotherapy for Ulcerative Colitis FACTU
• Scientific title: Faecal Bacteriotherapy for Ulcerative Colitis
• Date of first enrolment: June 19, 2017
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03104036
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Czech Republic, Czechia

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Mesalazine 4G Enema

Other: Faecal bacterial transplantation

Primary Outcome(s)

Clinical remission [Time Frame: Week 12]

Secondary Outcome(s)

Clinical response [Time Frame: Week 6 and 12]

Endoscopic remission [Time Frame: Week 6 and 12]

Secondary ID(s)

F16-27449A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institute of Animal Physiology and Genetics Academy of Science Czech Republic