Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
NCT ID: NCT04687150
Last Updated: 2022-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-01-01
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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The study group
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
Fecal microbiota transplantation
Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
The control group
The control group will be given colored water at same timepoints
Colored water
Colored water (placebo)
Interventions
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Fecal microbiota transplantation
Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
Colored water
Colored water (placebo)
Eligibility Criteria
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Inclusion Criteria
* Active newly diagnosed colitis (Mayo score \<11)
* Signed informed consent
Exclusion Criteria
* Gastrointestinal infection
* Pregnancy
* Antibiotic therapy at the baseline
* On-going probiotic medication
* Unable to provide signed informed consent
18 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Päijänne Tavastia Central Hospital
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Kimmo Salminen
MD, PhD, Specialist in Gastroenterology
Principal Investigators
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Kimmo K Salminen, MD,PhD
Role: STUDY_DIRECTOR
Head of the section
Locations
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Kimmo Salminen
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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T298/2020
Identifier Type: -
Identifier Source: org_study_id
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