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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 30, 2020
First Posted Date  ICMJE December 29, 2020
Last Update Posted Date October 19, 2022
Actual Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2020)		 Modified gut microbiota composition [ Time Frame: at week 12 ]
Increased species richness and alfa-diversity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
Official Title  ICMJE Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Other: Fecal microbiota transplantation
    Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
  • Other: Colored water
    Colored water (placebo)
Study Arms  ICMJE
  • 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
    Intervention: Other: Fecal microbiota transplantation
  • Placebo Comparator: The control group
    The control group will be given colored water at same timepoints
    Intervention: Other: Colored water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2020)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kimmo K Salminen, MD, PhD +35823130691 kimmo.salminen@tyks.fi
Contact: Jaakko Rautakorpi, MD +358238027 jaakko.rautakorpi@tyks.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04687150
Other Study ID Numbers  ICMJE T298/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kimmo Salminen, Turku University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Turku University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Helsinki University Central Hospital
  • Päijänne Tavastia Central Hospital
Investigators  ICMJE
Study Director: Kimmo K Salminen, MD,PhD Head of the section
PRS Account Turku University Hospital
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP