FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

NCT03391817 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-08-15

No results posted yet for this study

Summary

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.

Conditions

  • Obesity, Morbid

Interventions

OTHER

Fecal microbiota transplantation

Fecal microbiota transplantation administered in gastroscopy

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER
  • Helsinki University Central Hospital

    collaborator OTHER
  • Joint Authority for Päijät-Häme Social and Health Care

    lead OTHER

Principal Investigators

  • Perttu Arkkila, PhD MD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03391817 on ClinicalTrials.gov