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RecruitingNCT03732131FINFMTUpdated Feb 17, 2020

The Finnish Faecal Microbiota Transplantation Study (FINFMT)

An observational study in Faecal Microbiota Transplantation, sponsored by Joint Authority for Päijät-Häme Social and Health Care. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Joint Authority for Päijät-Häme Social and Health Care · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2021, 4 years 11 months ago, but the record still lists the study as recruiting.
  • Started Oct 2018; still recruiting 8 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 120 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Faecal Microbiota Transplantation
03

In context

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 18 years age
  • receiving FMT for rCDI or any other madical condition
  • written consent
  • Not included in other FMT trials

Exclusion criteria

Exclusion Criteria:

  • Unable to provide written consent
  • \< 18 years age
  • Included in other FMT-trial
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2018 (actual). Primary completion is estimated for Dec 2021, 38 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2018
First posted
Nov 6, 2018
StartActual
Oct 18, 2018
Primary completionEst.
Dec 2021
CompletionEst.
Jan 15, 2029
Last update
Feb 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03732131
Lead sponsor
Joint Authority for Päijät-Häme Social and Health Care
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
First posted
Nov 6, 2018
Start date
Oct 18, 2018
Primary completion
Dec 2021 (estimated)
Completion
Jan 15, 2029 (estimated)
Last update
Feb 17, 2020

Study contacts

Perttu Lahtinen, MD
Contact
perttu.lahtinen@phhyky.fi
+358-3-819 11
Perttu Arkkila, PhD
study director · Head of Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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