Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04687150
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Turku University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kimmo K Salminen, MD,PhD
Principal Investigator Affiliation Head of the section
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Finland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

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

Placebo Comparator: The control group

The control group will be given colored water at same timepoints

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kimmo Salminen, Turku, Finland

Status

Recruiting

Address

Kimmo Salminen

Turku, , 20521

Site Contact

Kimmo K Salminen, MD, PhD

kimmo.salminen@tyks.fi

+35823130691