FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

August 14, 2019 updated by: Joint Authority for Päijät-Häme Social and Health Care

FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY

40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Recruiting
        • Helsinki University Hospital
        • Contact:
      • Lahti, Finland
        • Recruiting
        • Päijät-Häme Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Candidates for the bariatric surgery

BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.

  • Availability of consecutive fecal samples during one year
  • Compliance to attend gastroscopy and FMT
  • 18-65 years

Exclusion Criteria:

  • Unable to provide informed consent
  • Pregnancy
  • Type I Diabetes Mellitus
  • Severe renal insufficiency, GFR<30%
  • Chronic or recurrent bacterial infection needing antimicrobial treatment
  • Large hiatal hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention arm
Fecal transplant from a thin donor
Other: Fecal microbiota transplantation
Fecal microbiota transplantation administered in gastroscopy
Placebo Comparator: Placebo arm
Fecal transplant made from patients own feces
Other: Fecal microbiota transplantation
Fecal microbiota transplantation administered in gastroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of weight
Time Frame: 1,5 years
1,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Collaborators

Helsinki University Central Hospital
University of Helsinki

Investigators

  • Study Director: Perttu Arkkila, PhD MD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2018

Primary Completion (Anticipated)

February 28, 2021

Study Completion (Anticipated)

February 28, 2021

Study Registration Dates

First Submitted

December 30, 2017

First Submitted That Met QC Criteria

December 30, 2017

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMTOBE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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