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Active Not Recruiting
NCT05607745
Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study
Conditions: NAFLD, Fecal Microbiota, Gut Microbiota, Obesity, Dietary Habits, Diet, Fecal Microbiota Transplantation, Glucose Metabolism Disorders, Nutrition, Healthy
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 54
Sponsor: University of Eastern Finland
Location: Finland
Summary
There are several studies performed to reveal the linkage between diet, fecal microbiota, and obesity.
Human fecal microbiota transplantations in this asset are still scarce.
Therefore, this pilot study of FMT from lean to obese people with dietary counseling will increase the knowledge, whether FMT could play a role in the treatment of obesity and NAFLD.
Our primary outcome is the changes in glucose metabolism by HOMA-IR.
Eligibility Criteria
Inclusion Criteria:Body mass index (BMI) ≥30 kg/m2Age 18-75 yearsSigned informed consentAbility to take part in a group-based nutrition adviceAdequate Finnish comprehension (since all advice and materials are in Finnish)Exclusion Criteria:Unable to provide written consentAttending another trial or having on-going dietary counseling at the same timePregnancy, breast feedingType I diabetesInflammatory diseaseLiver disease other than NAFLDExcess 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 herniaHistory of a severe (anaphylactic) food allergyActive, serious medical disease with likely life expectancy less than 5 yearsSevere renal insufficiency (glomerular filtration rate <30%)Procedures that have changed the anatomy of GI-tract, including obesity surgeryRemarkable psychiatric disorders, dementia and other diseases or conditions that could affect to the study subject´s compliance to the studySystemic antibacterial treatmentsthree months before the study or during the studychronic or recurrent bacterial infection for which antimicrobial medications are repeatedly usedContraindication for gastroscopyCentral anesthesia needed for gastroscopyMedications for losing weight (bupropion/naltrexon, orlistat, liraglutide)Intention to obesity surgery.Eligibility is evaluated by a doctor in each research unit.
Source: ClinicalTrials.gov (NCT05607745). StuddyBuddy aggregates publicly available trial information.