Obesity, Morbid
Conditions
Brief 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.
Interventions
OTHERFecal microbiota transplantation
Fecal microbiota transplantation administered in gastroscopy
Sponsors
University of Helsinki
Helsinki University Central Hospital
Joint Authority for Päijät-Häme Social and Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of weight | 1,5 years |
Countries
Finland
Contacts
Primary ContactPerttu Lahtinen, MD
Outcome results
None listed