An interventional study of Fecal microbiota transplantation in Obesity, Morbid, sponsored by Joint Authority for Päijät-Häme Social and Health Care. Status unknown at 2 sites in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by Joint Authority for Päijät-Häme Social and Health Care · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Fecal transplant from a thin donor
Other: Fecal microbiota transplantation
Fecal transplant made from patients own feces
Other: Fecal microbiota transplantation
Fecal microbiota transplantation administered in gastroscopy
Reduction of weight
Time frame: 1,5 years
Plan to share: Undecided
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Joint Authority for Päijät-Häme Social and Health Care