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Trial record 7 of 92 for:    Recruiting Studies | fecal microbiota transplantation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03732131
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Helsinki University
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
Information provided by (Responsible Party):
Joint Authority for Päijät-Häme Social and Health Care

Brief 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.

Condition or disease
Faecal Microbiota Transplantation

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 15, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Plasma, feces


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732131


Contacts
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Contact: Perttu Lahtinen, MD +358-3-819 11 perttu.lahtinen@phhyky.fi

Locations
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Finland
Joint Authority for Päijät-Häme Social and Health Care Recruiting
Lahti, Finland, 15850
Contact: Perttu Lahtinen, MD    +358-3-81911    perttu.lahtinen@phhyky.fi   
Sponsors and Collaborators
Joint Authority for Päijät-Häme Social and Health Care
Helsinki University
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
Investigators
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Study Director: Perttu Arkkila, PhD Head of Department

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Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT03732131     History of Changes
Other Study ID Numbers: HUS/3198/2017
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No