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

Turku University Hospital (TYKS)

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Other: Colored water; Other: Fecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04687150

T298/2020

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

The study group

Active Comparator group

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

Treatment:

Other: Fecal microbiota transplantation

The control group

Placebo Comparator group

Description:

The control group will be given colored water at same timepoints

Treatment:

Other: Colored water