The Finnish Faecal Microbiota Transplantation Study (FINFMT) (FINFMT)

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.

Study Overview

• Status: Recruiting
• Conditions: Faecal Microbiota Transplantation

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Perttu Lahtinen, MD; Phone Number: +358-3-819 11; Email: perttu.lahtinen@phhyky.fi

Study Locations

• Finland
  • Lahti, Finland, 15850
    • Recruiting
    • Joint Authority for Päijät-Häme Social and Health Care
    • Contact: Perttu Lahtinen, MD; Phone Number: +358-3-81911; Email: perttu.lahtinen@phhyky.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 118 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Collaborators and Investigators

• Sponsor: Joint Authority for Päijät-Häme Social and Health Care
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Oulu University Hospital; Kuopio University Hospital; University of Helsinki; Seinajoki Central Hospital; Tampere University Hospital; Vaasa Central Hospital, Vaasa, Finland; South Karelia, Social and Health Care District; Satakunta Central Hospital; Jyväskylä Central Hospital; North Karelia Central Hospital; Kanta-Häme Central Hospital; Mikkeli Central Hospital; Lapland Central Hospital; Keski-Pohjanmaa Central Hospital; Kymenlaakso Social and Health Services; Kainuu Social and Health Care Joint Authority
• Investigators: Study Director: Perttu Arkkila, PhD, head of department

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 15, 2029

Study Registration Dates

• First Submitted: November 4, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HUS/3198/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No