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

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ClinicalTrials.gov Identifier: NCT04687150
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : October 19, 2022
Sponsor:
Collaborators:
Helsinki University Central Hospital
Päijänne Tavastia Central Hospital
Information provided by (Responsible Party):
Kimmo Salminen, Turku University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Fecal microbiota transplantation Other: Colored water Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: e
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Modified gut microbiota composition [ Time Frame: at week 12 ]
    Increased species richness and alfa-diversity


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04687150


Contacts
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Contact: Kimmo K Salminen, MD, PhD +35823130691 kimmo.salminen@tyks.fi
Contact: Jaakko Rautakorpi, MD +358238027 jaakko.rautakorpi@tyks.fi

Locations
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Finland
Kimmo Salminen Recruiting
Turku, Finland, 20521
Contact: Kimmo K Salminen, MD, PhD    +35823130691    kimmo.salminen@tyks.fi   
Contact: Jaakko Rautakorpi, MD    +35823138027    jaakko.rautakorpi@tyks.fi   
Sponsors and Collaborators
Turku University Hospital
Helsinki University Central Hospital
Päijänne Tavastia Central Hospital
Investigators
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Study Director: Kimmo K Salminen, MD,PhD Head of the section
More Information
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Responsible Party: Kimmo Salminen, MD, PhD, Specialist in Gastroenterology, Turku University Hospital
ClinicalTrials.gov Identifier: NCT04687150    
Other Study ID Numbers: T298/2020
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases