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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03104036
Other study ID # F16-27449A
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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