Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC) (FinUC)

Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Fecal microbiota transplantation; Other: Colored water

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimmo K Salminen, MD, PhD; Phone Number: +35823130691; Email: kimmo.salminen@tyks.fi
• Study Contact Backup: Name: Jaakko Rautakorpi, MD; Phone Number: +358238027; Email: jaakko.rautakorpi@tyks.fi

Study Locations

• Finland
  • Turku, Finland, 20521
    • Recruiting
    • Kimmo Salminen
    • Contact: Kimmo K Salminen, MD, PhD; Phone Number: +35823130691; Email: kimmo.salminen@tyks.fi
    • Contact: Jaakko Rautakorpi, MD; Phone Number: +35823138027; Email: jaakko.rautakorpi@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Other: Fecal microbiota transplantation; Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
PLACEBO_COMPARATOR: The control group; The control group will be given colored water at same timepoints	Other: Colored water; Colored water (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified gut microbiota composition	Increased species richness and alfa-diversity	at week 12

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Helsinki University Central Hospital; Päijänne Tavastia Central Hospital
• Investigators: Study Director: Kimmo K Salminen, MD,PhD, Head of the section

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 26, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: T298/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No