FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

Joint Authority for Päijät-Häme Social and Health Care40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obesity, Morbid

Interventions

Fecal microbiota transplantationOTHER

Fecal microbiota transplantation administered in gastroscopy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Päijät-Häme Central Hospital

Lahti, Finland

RECRUITING

Outcomes

Primary Outcomes

Reduction of weight

Time frame: 1,5 years

Central Contacts

Perttu Lahtinen, MD

CONTACT

+358447195256 perttu.lahtinen@phhyky.fi

Data from ClinicalTrials.gov

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