Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Other: Colored water; Other: Fecal microbiota transplantation

• Registration Number: NCT04687150
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-26
• Study First Posted: 2020-12-29
• Study Start: 2021-01-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group	Colored water	The control group will be given colored water at same timepoints
The study group	Fecal microbiota transplantation	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

Primary Outcome Measures

Name	Time	Method
Modified gut microbiota composition	at week 12	Increased species richness and alfa-diversity

Trial Locations

Locations (1)

Kimmo Salminen; 🇫🇮 Turku, Finland