Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study (DIFTOB)
NAFLD, Fecal Microbiota, Gut Microbiota
About this trial
This is an interventional basic science trial for NAFLD
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) ≥30 kg/m2 Age 18-75 years Signed informed consent Ability to take part in a group-based nutrition advice Adequate Finnish comprehension (since all advice and materials are in Finnish) Exclusion Criteria: Unable to provide written consent Attending another trial or having on-going dietary counseling at the same time Pregnancy, breast feeding Type I diabetes Inflammatory disease Liver disease other than NAFLD Excess alcohol consumption (more than 20 g/day in females and more than 30 g/day in males, on average) Dysmotility of upper GI-tract (e.g. gastroparesis) Big hiatal hernia History of a severe (anaphylactic) food allergy Active, serious medical disease with likely life expectancy less than 5 years Severe renal insufficiency (glomerular filtration rate <30%) Procedures that have changed the anatomy of GI-tract, including obesity surgery Remarkable psychiatric disorders, dementia and other diseases or conditions that could affect to the study subject´s compliance to the study Systemic antibacterial treatments three months before the study or during the study chronic or recurrent bacterial infection for which antimicrobial medications are repeatedly used Contraindication for gastroscopy Central anesthesia needed for gastroscopy Medications for losing weight (bupropion/naltrexon, orlistat, liraglutide) Intention to obesity surgery. Eligibility is evaluated by a doctor in each research unit.
Sites / Locations
- Helsinki University Hospital
- University of Eastern Finland
- Lahti Central Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
FMT
Placebo
Fecal transplantation is given 2:1 compared to placebo transplantation via gastroscopy as a fluid of 100-150ml. Similar healthy diet counseling is given to all participants in both FMT and placebo group.
Placebo is brown-colored water and given the same way than fecal transplantation fluid. All study subjects receive similar dietary advice based on healthy diet. Similar healthy diet counseling is given to all participants in both FMT and placebo group.