The Finnish Faecal Microbiota Transplantation Study (FINFMT)

Faecal Microbiota Transplantation Clinical Trial

— FINFMT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03732131
• Other study ID #: HUS/3198/2017
• Status: Recruiting
• Start date: October 18, 2018
• Est. completion date: January 15, 2029

Study information

• Verified date: February 2020
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: Perttu Lahtinen, MD
• Phone: +358-3-819 11
• Email: perttu.lahtinen[@]phhyky.fi
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 15, 2029
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Faecal Microbiota Transplantation

Locations

Country	Name	City	State
Finland	Joint Authority for Päijät-Häme Social and Health Care	Lahti

Sponsors (19)

Lead Sponsor

Collaborator

Joint Authority for Päijät-Häme Social and Health Care

Helsinki University, 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, Vaasa Central Hospital, Vaasa, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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