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NCT04687150 Clinical Trial

Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)

Ulcerative Colitis Clinical Trial

— FinUC  

Official title:
Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04687150
Other study ID # T298/2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date March 2024

Study information
Verified date October 2022
Source Turku University Hospital
Contact Kimmo K Salminen, MD, PhD
Phone +35823130691
Email kimmo.salminen@tyks.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Fecal microbiota transplantation
Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
• Colored water
Colored water (placebo)

Locations
Country Name City State
Finland Kimmo Salminen Turku

Sponsors (3)
Lead Sponsor Collaborator
Turku University Hospital Helsinki University Central Hospital, Päijänne Tavastia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Modified gut microbiota composition Increased species richness and alfa-diversity at week 12
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