NCT03732131

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Oct 2018Jan 2029

Study Start

First participant enrolled

October 18, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2029

Expected
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

3.1 years

First QC Date

November 4, 2018

Last Update Submit

February 13, 2020

Conditions

Faecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Authority for Päijät-Häme Social and Health Care

Lahti, 15850, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, feces

Study Officials

  • Perttu Arkkila, PhD

    Head of Department

    STUDY DIRECTOR

Central Study Contacts

Perttu Lahtinen, MD

CONTACT

+358-3-819 11perttu.lahtinen@phhyky.fi

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 6, 2018

Study Start

October 18, 2018

Primary Completion

December 1, 2021

Study Completion (Estimated)

January 15, 2029

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)