Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Faecal Bacteriotherapy for Ulcerative Colitis (FACTU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03104036
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Institute of Animal Physiology and Genetics Academy of Science Czech Republic
Information provided by (Responsible Party):
Jan Březina, Institute for Clinical and Experimental Medicine

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Faecal bacterial transplantation Drug: Mesalazine 4G Enema Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Faecal Bacteriotherapy for Ulcerative Colitis
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mesalazine enema
Will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week.
Drug: Mesalazine 4G Enema
Standard mesalazine enema

Experimental: Faecal bacterial transplantation enema
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.
Other: Faecal bacterial transplantation
Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline
Other Name: FMT




Primary Outcome Measures :
  1. Clinical remission [ Time Frame: Week 12 ]
    Mayo score ≤ 2 with no subscore > 1


Secondary Outcome Measures :
  1. Endoscopic remission [ Time Frame: Week 6 and 12 ]
    Mayo endoscopic score = 0

  2. Clinical response [ Time Frame: Week 6 and 12 ]
    Decrease of Mayo score ≥ 2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104036


Contacts
Layout table for location contacts
Contact: Jan Brezina, M.D. 00420739602520 jan.brezina@ikem.cz

Locations
Layout table for location information
Czechia
Gastroenterology departement Hospital České Budějovice Recruiting
Ceske Budejovice, Jihočeský Kraj, Czechia, 370 01
Contact: Olga Shonová, M.D.       shonova@nemcb.cz   
Centrum péče o zažívací trakt Vítkovická nemocnice Recruiting
Ostrava - Vitkovice, Moravskoslezský Kraj, Czechia, 703 84
Contact: Barbora Pipek, M.D.       barbora.pipek@seznam.cz   
Second department of internal medicine of University Hospital Olomouc Recruiting
Olomouc, Olomoucký Kraj, Czechia, 77900
Contact: Michal Konečný, M.D.       michal.konecny@fnol.cz   
IV. Department of Internal Medicine, General University Hospital in Prague Recruiting
Prague, Prague 2, Czechia, 128 08
Contact: Pavel Hrabák, M.D.       pavel.hrabak@vfn.cz   
Internal departement of Thomayer Hospital Recruiting
Prague, Prague 4, Czechia, 14059
Contact: Jiří Vejmelka, M.D.       jiri.vejmelka@ftn.cz   
ISCARE Recruiting
Prague, Prague 7, Czechia, 17004
Contact: Martin Bortlík, M.D.       mbortlik@seznam.cz   
II. Department of Internal Medicine University Hospital Vinohrady Recruiting
Prague, Czechia, 100 34
Contact: Ivana Cibulková, M.D.       ivana.cibulkova@fnkv.cz   
Institute of clinical and experimental medicine Recruiting
Prague, Czechia, 14021
Contact: Jan Brezina, M.D.    00420739602520    jan.brezina@ikem.cz   
Internal departement Hospital Na Bulovce Recruiting
Prague, Czechia, 150 00
Contact: Karel Mareš, M.D.       karel.mares@homolka.cz   
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Institute of Animal Physiology and Genetics Academy of Science Czech Republic

Layout table for additonal information
Responsible Party: Jan Březina, MUDr. (principal investigator), Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03104036     History of Changes
Other Study ID Numbers: F16-27449A
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jan Březina, Institute for Clinical and Experimental Medicine:
Feacal bacterial transplantation
Left-sided ulcerative colitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents