Faecal Microbiota TransplantationFINFMTNCT03732131
The Finnish Faecal Microbiota Transplantation Study (FINFMT)
An observational study of Faecal Microbiota Transplantation, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial summary
The objective of the study is to follow up the long term effects of faecal microbiota tranplantation (FMT). All the over 18 years old patients receiving FMT and not included in other trials meet inclusion criteria to this study. Patients will be asked for a written consent. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Faecal Microbiota Transplantation
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 18 Oct 2018to 15 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Finnish patients over 18 years of age. Receiving FMT for recurring Clostridium difficile infektion (rCDI) which is the only indication for FMT. If experimental FMT would be given for any other condition after a throughout work up of a collegue of experts such a patien would meet inclusion criteria as well.
Who may be able to join
- > 18 years age
- receiving FMT for rCDI or any other madical condition
- written consent
- Not included in other FMT trials
Who cannot join
- Unable to provide written consent
- < 18 years age
- Included in other FMT-trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Joint Authority for Päijät-Häme Social and Health Care
Lahti, 15850
Perttu Lahtinen, MD, +358-3-81911, perttu.lahtinen@phhyky.fi
About this study
Official title: Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study
The objective of the study is to follow up the long term effects of faecal microbiota tranplantation (FMT). All the over 18 years old patients receiving FMT and not included in other trials meet inclusion criteria to this study. Patients will be asked for a written consent. The outcome and possible side effects of the FMT will be followed by blood and feces samples for one year and with questionaires up to ten years after the FMT.
- Conditions
- Faecal Microbiota Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
The long term effects of FMT -questionnaire
The questionnaire has 52 questions. Weight and height are asked and appearance of certain symptoms. The answers are mostly yes or no. The questionnaire is not validated and it is descriptive and the answers are not scored.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start18 Oct 2018
- Primary completionDec 2021 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal Microbiota TransplantationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Helsinki University Central Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Kuopio University Hospital, South Karelia, Social and Health Care District, North Karelia Central Hospital, Keski-Pohjanmaa Central Hospital, Seinajoki Central Hospital, Jyväskylä Central Hospital, Kanta-Häme Central Hospital, Mikkeli Central Hospital, Vaasa Central Hospital, Vaasa, Finland, Lapland Central Hospital, Satakunta Central Hospital, Kymenlaakso Social and Health Services, Kainuu Social and Health Care Joint Authority
- Responsible party
- Sponsor
- Investigators
- Perttu Arkkila, PhD, Study director, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732131
- Sponsor's protocol ID
- HUS/3198/2017
- Acronym
- FINFMT
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2018
- Last updated
- 17 Feb 2020
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study
- ClinicalTrials.gov ID
- NCT03732131
- Acronym / sponsor ID
- FINFMT / HUS/3198/2017
- Conditions
- Faecal Microbiota Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- University of Helsinki, Helsinki University Central Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Kuopio University Hospital, South Karelia, Social and Health Care District, North Karelia Central Hospital, Keski-Pohjanmaa Central Hospital, Seinajoki Central Hospital, Jyväskylä Central Hospital, Kanta-Häme Central Hospital, Mikkeli Central Hospital, Vaasa Central Hospital, Vaasa, Finland, Lapland Central Hospital, Satakunta Central Hospital, Kymenlaakso Social and Health Services, Kainuu Social and Health Care Joint Authority
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 6 Nov 2018 (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.
The objective of the study is to follow up the long term effects of faecal microbiota tranplantation (FMT). All the over 18 years old patients receiving FMT and not included in other trials meet inclusion criteria to this study. Patients will be asked for a written consent. The outcome and possible side effects of the FMT will be followed by blood and feces samples for one year and with questionaires up to ten years after the FMT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Finnish patients over 18 years of age. Receiving FMT for recurring Clostridium difficile infektion (rCDI) which is the only indication for FMT. If experimental FMT would be given for any other condition after a throughout work up of a collegue of experts such a patien would meet inclusion criteria as well.
Key inclusion criteria (4 listed)
- > 18 years age
- receiving FMT for rCDI or any other madical condition
- written consent
- Not included in other FMT trials
Key exclusion criteria (3 listed)
- Unable to provide written consent
- < 18 years age
- Included in other FMT-trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The long term effects of FMT -questionnaire
Time frame: 10 years
The questionnaire has 52 questions. Weight and height are asked and appearance of certain symptoms. The answers are mostly yes or no. The questionnaire is not validated and it is descriptive and the answers are not scored.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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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.
Perttu Arkkila, PhD study director
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Faecal Microbiota Transplantation, run by Joint Authority for Päijät-Häme Social and Health Care 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Feb 2020. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perttu Lahtinen, MD (+358-3-819 11, perttu.lahtinen@phhyky.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The long term effects of FMT -questionnaire (time frame: 10 years). 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 17 Feb 2020.