Ulcerative ColitisFinUCNCT04687150
Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
A study testing Fecal microbiota transplantation and Colored water in people with Ulcerative Colitis, run by Turku University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Fecal microbiota transplantation and Colored water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2021to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years
- Active newly diagnosed colitis (Mayo score <11)
- Signed informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Kimmo Salminen
Turku, 20521
Kimmo K Salminen, MD, PhD, +35823130691, kimmo.salminen@tyks.fi
Jaakko Rautakorpi, MD, +35823138027, jaakko.rautakorpi@tyks.fi
About this study
Official title: Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal microbiota transplantation, Colored water
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationOther
Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
Colored waterOther
Colored water (placebo)
| Study group | Role | What they receive |
|---|---|---|
| The study group | Active comparator | 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 Receives: Other: Fecal microbiota transplantation |
| The control group | Placebo comparator | The control group will be given colored water at same timepoints Receives: Other: Colored water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified gut microbiota composition
Increased species richness and alfa-diversity
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2021
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Helsinki University Central Hospital, Päijänne Tavastia Central Hospital
- Responsible party
- Principal investigator, Kimmo Salminen, Turku University Hospital
- Investigators
- Kimmo K Salminen, MD,PhD, Study director, Head of the section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687150
- Sponsor's protocol ID
- T298/2020
- Acronym
- FinUC
- Status last verified
- Oct 2022
- First submitted
- 30 Nov 2020
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT04687150
- Acronym / sponsor ID
- FinUC / T298/2020
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Helsinki University Central Hospital, Päijänne Tavastia Central Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).
| Arm | Type | Receives |
|---|---|---|
| The study group | Active comparator | Other: Fecal microbiota transplantationThe 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 | Placebo comparator | Other: Colored waterThe control group will be given colored water at same timepoints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years
- Active newly diagnosed colitis (Mayo score <11)
- Signed informed consent
Key exclusion criteria (6 listed)
- Fulminant severe colitis (Mayo score 11-12 or Truelove and Witts criteria)
- Gastrointestinal infection
- Pregnancy
- Antibiotic therapy at the baseline
- On-going probiotic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantationFecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank | Other | The study group |
| Colored waterColored water (placebo) | Other | The control group |
Primary outcome
Modified gut microbiota composition
Time frame: at week 12
Increased species richness and alfa-diversity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimmo K Salminen, MD,PhD study director
Head of the section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation and Colored water in people with Ulcerative Colitis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimmo K Salminen, MD, PhD (+35823130691, kimmo.salminen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified gut microbiota composition (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.