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NCT Number: NCT03732131

The Finnish Faecal Microbiota Transplantation Study (FINFMT)

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.

Recruiting

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Key information

Conditions

Faecal Microbiota Transplantation

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Joint Authority for Päijät-Häme Social and Health Care

Lahti, 15850, Finland

Location status: Recruiting

Location contact

Perttu Lahtinen, MD

CONTACT

[email protected]

+358-3-81911

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Perttu Lahtinen, MD

CONTACT

[email protected]

+358-3-819 11

Sponsors and collaborators

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care

Other

Collaborators

  • Helsinki University Central Hospital
  • Jyväskylä Central Hospital
  • Kainuu Social and Health Care Joint Authority
  • Kanta-Häme Central Hospital
  • Keski-Pohjanmaa Central Hospital
  • Kuopio University Hospital
  • Kymenlaakso Social and Health Services
  • Lapland Central Hospital
  • Mikkeli Central Hospital
  • North Karelia Central Hospital
  • Oulu University Hospital
  • Satakunta Central Hospital
  • Seinajoki Central Hospital
  • South Karelia, Social and Health Care District
  • Tampere University Hospital
  • Turku University Hospital
  • University of Helsinki
  • Vaasa Central Hospital, Vaasa, Finland

Registry information

Official study title

Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study

Acronym: FINFMT

Important dates

Study start
2018
Primary completion
2021
Study completion
2029
First posted
Nov 6, 2018
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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