Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC) (FinUC)
Primary Purpose
Ulcerative Colitis
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Colored water
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- Over 18 years
- Active newly diagnosed colitis (Mayo score <11)
- Signed informed consent
Exclusion Criteria:
- Fulminant severe colitis (Mayo score 11-12 or Truelove and Witts criteria)
- Gastrointestinal infection
- Pregnancy
- Antibiotic therapy at the baseline
- On-going probiotic medication
- Unable to provide signed informed consent
Sites / Locations
- Kimmo SalminenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
The study group
The control group
Arm Description
The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit
The control group will be given colored water at same timepoints
Outcomes
Primary Outcome Measures
Modified gut microbiota composition
Increased species richness and alfa-diversity
Secondary Outcome Measures
Full Information
NCT ID
NCT04687150
First Posted
November 30, 2020
Last Updated
October 18, 2022
Sponsor
Turku University Hospital
Collaborators
Helsinki University Central Hospital, Päijänne Tavastia Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04687150
Brief Title
Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
Acronym
FinUC
Official Title
Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
Helsinki University Central Hospital, Päijänne Tavastia Central Hospital
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
In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.
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
Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).
Masking
ParticipantCare ProviderInvestigator
Masking Description
e
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The study group
Arm Type
Active Comparator
Arm Description
The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
The control group will be given colored water at same timepoints
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
Intervention Type
Other
Intervention Name(s)
Colored water
Intervention Description
Colored water (placebo)
Primary Outcome Measure Information:
Title
Modified gut microbiota composition
Description
Increased species richness and alfa-diversity
Time Frame
at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years
Active newly diagnosed colitis (Mayo score <11)
Signed informed consent
Exclusion Criteria:
Fulminant severe colitis (Mayo score 11-12 or Truelove and Witts criteria)
Gastrointestinal infection
Pregnancy
Antibiotic therapy at the baseline
On-going probiotic medication
Unable to provide signed informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimmo K Salminen, MD, PhD
Phone
+35823130691
Email
kimmo.salminen@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jaakko Rautakorpi, MD
Phone
+358238027
Email
jaakko.rautakorpi@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimmo K Salminen, MD,PhD
Organizational Affiliation
Head of the section
Official's Role
Study Director
Facility Information:
Facility Name
Kimmo Salminen
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimmo K Salminen, MD, PhD
Phone
+35823130691
Email
kimmo.salminen@tyks.fi
First Name & Middle Initial & Last Name & Degree
Jaakko Rautakorpi, MD
Phone
+35823138027
Email
jaakko.rautakorpi@tyks.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
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