Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
FinUC
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 29, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedOctober 19, 2022
October 1, 2022
2.9 years
November 30, 2020
October 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Modified gut microbiota composition
Increased species richness and alfa-diversity
at week 12
Study Arms (2)
The study group
ACTIVE COMPARATORThe 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
PLACEBO COMPARATORThe control group will be given colored water at same timepoints
Interventions
Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
Eligibility Criteria
You may qualify if:
- Over 18 years
- Active newly diagnosed colitis (Mayo score \<11)
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- Helsinki University Central Hospitalcollaborator
- Päijänne Tavastia Central Hospitalcollaborator
Study Sites (1)
Kimmo Salminen
Turku, 20521, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kimmo K Salminen, MD,PhD
Head of the section
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- e
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Specialist in Gastroenterology
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 29, 2020
Study Start
January 1, 2021
Primary Completion
December 1, 2023
Study Completion
March 1, 2024
Last Updated
October 19, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share