NCT03732131|Recruiting
The Finnish Faecal Microbiota Transplantation Study (FINFMT)
FINFMT
Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study
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FINFMT
Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study
Sponsor study identifier
observational
200
1 country
1
Study Start
October 18, 2018
Actual (reported)Primary Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 2018
Actual (reported)November 4, 2018
Actual (reported)November 6, 2018
Actual (reported)December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
Joint Authority for Päijät-Häme Social and Health Care
Lahti, 15850, Finland
Plasma, feces
Perttu Arkkila, PhD
Head of Department
First Submitted
November 4, 2018
First Posted
November 6, 2018
Study Start
October 18, 2018
Actual (reported)Primary Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
January 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 17, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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