Ulcerative Colitis
Conditions
Keywords
Feacal bacterial transplantation, Left-sided ulcerative colitis
Brief 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.
Interventions
OTHERFaecal bacterial transplantation
Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline
DRUGMesalazine 4G Enema
Standard mesalazine enema
Sponsors
Institute of Animal Physiology and Genetics Academy of Science Czech Republic
Institute for Clinical and Experimental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be split into two branches of the study by randomization criteria (gender, imunosupresive therapy). Each branch of the study will have 25-30 patients. The first group will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. A second group of patients 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | Week 12 | Mayo score ≤ 2 with no subscore \> 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic remission | Week 6 and 12 | Mayo endoscopic score = 0 |
| Clinical response | Week 6 and 12 | Decrease of Mayo score ≥ 2 |
Countries
Czechia
Outcome results
None listed