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Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)

Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04687150
Acronym
FinUC
Enrollment
20
Registered
2020-12-29
Start date
2021-01-01
Completion date
2024-03-31
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

OTHERFecal microbiota transplantation

Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank

OTHERColored water

Colored water (placebo)

Sponsors

Helsinki University Central Hospital
CollaboratorOTHER
Päijänne Tavastia Central Hospital
CollaboratorOTHER
Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

e

Intervention model description

Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified gut microbiota compositionat week 12Increased species richness and alfa-diversity

Countries

Finland

Contacts

Primary ContactKimmo K Salminen, MD, PhD
kimmo.salminen@tyks.fi+35823130691
Backup ContactJaakko Rautakorpi, MD
jaakko.rautakorpi@tyks.fi+358238027

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026