Back to resultsFaecal Bacteriotherapy for Ulcerative Colitis (FACTU)
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
Faecal bacterial transplantation
Mesalazine 4G Enema
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Feacal bacterial transplantation, Left-sided ulcerative colitis
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
Sites / Locations
- Gastroenterology departement Hospital České Budějovice
- Centrum péče o zažívací trakt Vítkovická nemocnice
- Second department of internal medicine of University Hospital Olomouc
- IV. Department of Internal Medicine, General University Hospital in Prague
- Internal departement of Thomayer Hospital
- ISCARE
- II. Department of Internal Medicine University Hospital Vinohrady
- Institute of clinical and experimental medicine
- Internal departement Hospital Na Bulovce
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mesalazine enema
Faecal bacterial transplantation enema
Arm Description
Will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week.
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.
Outcomes
Primary Outcome Measures
Clinical remission
Mayo score ≤ 2 with no subscore > 1
Secondary Outcome Measures
Endoscopic remission
Mayo endoscopic score = 0
Clinical response
Decrease of Mayo score ≥ 2
Full Information
NCT ID
NCT03104036
First Posted
March 27, 2017
Last Updated
September 29, 2021
Sponsor
Institute for Clinical and Experimental Medicine
Collaborators
Institute of Animal Physiology and Genetics Academy of Science Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT03104036
Brief Title
Faecal Bacteriotherapy for Ulcerative Colitis
Acronym
FACTU
Official Title
Faecal Bacteriotherapy for Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Clinical and Experimental Medicine
Collaborators
Institute of Animal Physiology and Genetics Academy of Science Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Feacal bacterial transplantation, Left-sided ulcerative colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mesalazine enema
Arm Type
Active Comparator
Arm Description
Will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week.
Arm Title
Faecal bacterial transplantation enema
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Faecal bacterial transplantation
Other Intervention Name(s)
FMT
Intervention Description
Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline
Intervention Type
Drug
Intervention Name(s)
Mesalazine 4G Enema
Intervention Description
Standard mesalazine enema
Primary Outcome Measure Information:
Title
Clinical remission
Description
Mayo score ≤ 2 with no subscore > 1
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Endoscopic remission
Description
Mayo endoscopic score = 0
Time Frame
Week 6 and 12
Title
Clinical response
Description
Decrease of Mayo score ≥ 2
Time Frame
Week 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Gastroenterology departement Hospital České Budějovice
City
Ceske Budejovice
State/Province
Jihočeský Kraj
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Centrum péče o zažívací trakt Vítkovická nemocnice
City
Ostrava - Vitkovice
State/Province
Moravskoslezský Kraj
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
Second department of internal medicine of University Hospital Olomouc
City
Olomouc
State/Province
Olomoucký Kraj
ZIP/Postal Code
77900
Country
Czechia
Facility Name
IV. Department of Internal Medicine, General University Hospital in Prague
City
Prague
State/Province
Prague 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Internal departement of Thomayer Hospital
City
Prague
State/Province
Prague 4
ZIP/Postal Code
14059
Country
Czechia
Facility Name
ISCARE
City
Prague
State/Province
Prague 7
ZIP/Postal Code
17004
Country
Czechia
Facility Name
II. Department of Internal Medicine University Hospital Vinohrady
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Institute of clinical and experimental medicine
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Internal departement Hospital Na Bulovce
City
Prague
ZIP/Postal Code
150 00
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Faecal Bacteriotherapy for Ulcerative Colitis
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