Back to resultsFecal Microbiota Transplantation in Patients With Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Withdrawn
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed
Exclusion Criteria:
- severe ulcerative colitis (PUCAI > 65)
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Fecal microbiota transplantation
Standard medical treatment
Arm Description
A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment
Standard medical treatment as recommended by the ECCO Guidelines of UC therapy.
Outcomes
Primary Outcome Measures
Activity of ulcerative colitis
Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.
Secondary Outcome Measures
Colonic inflammation
Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months.
Colonic inflammation
Endoscopic Mayo score at 3 and 12 months after the intervention
Adverse events
Full Information
NCT ID
NCT01961492
First Posted
October 9, 2013
Last Updated
October 12, 2018
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01961492
Brief Title
Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
Official Title
Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Problems in recruiting
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal microbiota transplantation
Arm Type
Active Comparator
Arm Description
A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment
Arm Title
Standard medical treatment
Arm Type
No Intervention
Arm Description
Standard medical treatment as recommended by the ECCO Guidelines of UC therapy.
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
A single fecal microbiota transplantation through colonoscope
Primary Outcome Measure Information:
Title
Activity of ulcerative colitis
Description
Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.
Time Frame
Within 1 year after the intervention
Secondary Outcome Measure Information:
Title
Colonic inflammation
Description
Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months.
Time Frame
Within 1 year after the intervention
Title
Colonic inflammation
Description
Endoscopic Mayo score at 3 and 12 months after the intervention
Time Frame
Within 1 year after the intervention
Title
Adverse events
Time Frame
Within 1 year after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed
Exclusion Criteria:
severe ulcerative colitis (PUCAI > 65)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marko Kalliomäki, MD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
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