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 : November 8, 2019
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

Tracking Information
First Submitted Date  ICMJE March 27, 2017
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE June 19, 2017
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
Clinical remission [ Time Frame: Week 12 ]
Mayo score ≤ 2 with no subscore > 1
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03104036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • Endoscopic remission [ Time Frame: Week 6 and 12 ]
    Mayo endoscopic score = 0
  • Clinical response [ Time Frame: Week 6 and 12 ]
    Decrease of Mayo score ≥ 2
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Faecal Bacteriotherapy for Ulcerative Colitis
Official Title  ICMJE Faecal Bacteriotherapy for 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Other: Faecal bacterial transplantation
    Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline
    Other Name: FMT
  • Drug: Mesalazine 4G Enema
    Standard mesalazine enema
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Mesalazine 4G 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.
    Intervention: Other: Faecal bacterial transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan Brezina, M.D. 00420739602520 jan.brezina@ikem.cz
Listed Location Countries  ICMJE Czechia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT03104036
Other Study ID Numbers  ICMJE F16-27449A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jan Březina, Institute for Clinical and Experimental Medicine
Study Sponsor  ICMJE Institute for Clinical and Experimental Medicine
Collaborators  ICMJE Institute of Animal Physiology and Genetics Academy of Science Czech Republic
Investigators  ICMJE Not Provided
PRS Account Institute for Clinical and Experimental Medicine
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP