Back to resultsFecal Transplantation in Ulcerative Colitis (FMT-CU)
Primary Purpose
Ulcerative Colitis
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fecal microbiota transplantation (FMT)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
• • Diagnosis of CU based on clinical, endoscopic, and histological findings.
- Remission assessed by Mayo score (0 to 1) and F-Calpro (<100 ug/g).
- Availability of consecutive fecal samples during one year after the diagnosis of CU.
- Availability of blood sample to study the IBD associated genetic background
- Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
- 18-75 years
Exclusion Criteria:
- Unable to provide informed consent
- Need for any antibiotic therapy within 3 months
- Use of corticosteroids, immunosuppressive or biological medication at the baseline
- Use of any probiotics
- Pregnancy
Sites / Locations
- Helsinki University Hospital
- Päijät-Häme Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
FMT
Placebo
Arm Description
50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.
Outcomes
Primary Outcome Measures
Maintenance of remission of ulcerative colitis
Endoscopic remission and Mayo-score < 2
Secondary Outcome Measures
Full Information
NCT ID
NCT03561532
First Posted
June 6, 2018
Last Updated
August 14, 2019
Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Helsinki University Central Hospital, University of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT03561532
Brief Title
Fecal Transplantation in Ulcerative Colitis
Acronym
FMT-CU
Official Title
FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Helsinki University Central Hospital, University of Helsinki
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
Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.
Detailed Description
80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).
The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The participant and the treating personnel are blinded of the randomization result.
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMT
Arm Type
Active Comparator
Arm Description
50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantation (FMT)
Intervention Description
FMT administered into the cecum of the patient in colonoscopy.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.
Primary Outcome Measure Information:
Title
Maintenance of remission of ulcerative colitis
Description
Endoscopic remission and Mayo-score < 2
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• • Diagnosis of CU based on clinical, endoscopic, and histological findings.
Remission assessed by Mayo score (0 to 1) and F-Calpro (<100 ug/g).
Availability of consecutive fecal samples during one year after the diagnosis of CU.
Availability of blood sample to study the IBD associated genetic background
Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
18-75 years
Exclusion Criteria:
Unable to provide informed consent
Need for any antibiotic therapy within 3 months
Use of corticosteroids, immunosuppressive or biological medication at the baseline
Use of any probiotics
Pregnancy
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Päijät-Häme Central Hospital
City
Lahti
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.
Learn more about this trial
Fecal Transplantation in Ulcerative Colitis
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