Clinical trial NCT03104036: Faecal Bacteriotherapy for Ulcerative Colitis
Official title: Faecal Bacteriotherapy for Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Feacal bacterial transplantation
Left-sided ulcerative colitis
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Institute of Animal Physiology and Genetics Academy of Science Czech Republic
First posted: 2017-04-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical remission
timeFrame: Week 12
Secondary outcomes:
measure: Endoscopic remission
timeFrame: Week 6 and 12
measure: Clinical response
timeFrame: Week 6 and 12
Other outcomes:
Locations:
city: Ceske Budejovice
country: Czechia
facility: Gastroenterology departement Hospital České Budějovice
state: Jihočeský Kraj
city: Ostrava - Vitkovice
country: Czechia
facility: Centrum péče o zažívací trakt Vítkovická nemocnice
state: Moravskoslezský Kraj
city: Olomouc
country: Czechia
facility: Second department of internal medicine of University Hospital Olomouc
state: Olomoucký Kraj
city: Prague
country: Czechia
facility: IV. Department of Internal Medicine, General University Hospital in Prague
state: Prague 2
city: Prague
country: Czechia
facility: Internal departement of Thomayer Hospital
state: Prague 4
city: Prague
country: Czechia
facility: ISCARE
state: Prague 7
city: Prague
country: Czechia
facility: II. Department of Internal Medicine University Hospital Vinohrady
city: Prague
country: Czechia
facility: Institute of clinical and experimental medicine
city: Prague
country: Czechia
facility: Internal departement Hospital Na Bulovce
Study officials:
References: