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

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Colored water
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kimmo SalminenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

The study group

The control group

Arm Description

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 at same timepoints

Outcomes

Primary Outcome Measures

Modified gut microbiota composition
Increased species richness and alfa-diversity

Secondary Outcome Measures

Full Information

First Posted
November 30, 2020
Last Updated
October 18, 2022
Sponsor
Turku University Hospital
Collaborators
Helsinki University Central Hospital, Päijänne Tavastia Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04687150
Brief Title
Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
Acronym
FinUC
Official Title
Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
Helsinki University Central Hospital, Päijänne Tavastia Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).
Masking
ParticipantCare ProviderInvestigator
Masking Description
e
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The study group
Arm Type
Active Comparator
Arm Description
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
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
The control group will be given colored water at same timepoints
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
Intervention Type
Other
Intervention Name(s)
Colored water
Intervention Description
Colored water (placebo)
Primary Outcome Measure Information:
Title
Modified gut microbiota composition
Description
Increased species richness and alfa-diversity
Time Frame
at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimmo K Salminen, MD, PhD
Phone
+35823130691
Email
kimmo.salminen@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jaakko Rautakorpi, MD
Phone
+358238027
Email
jaakko.rautakorpi@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimmo K Salminen, MD,PhD
Organizational Affiliation
Head of the section
Official's Role
Study Director
Facility Information:
Facility Name
Kimmo Salminen
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimmo K Salminen, MD, PhD
Phone
+35823130691
Email
kimmo.salminen@tyks.fi
First Name & Middle Initial & Last Name & Degree
Jaakko Rautakorpi, MD
Phone
+35823138027
Email
jaakko.rautakorpi@tyks.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)

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