Clinical trial

Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05607745

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersAccepted
ConditionNAFLD, Fecal Microbiota, Gut Microbiota, Obesity, Dietary Habits, Diet, Fecal Microbiota Transplantation, Glucose Metabolism Disorders, Nutrition, Healthy

Full registry 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.

Treatments and study arms

FMT and placebo

Other

Similar healthy diet counseling is given to all participants in both FMT and placebo group. FMT to placebo is given in 2:1.

Primary outcomes

A change in HOMA-IRat week 12 and at week 52

A change in HOMA-IR at week 12 and week 52 in both study groups and hypothetically more in those with FMT compared to those with placebo.

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Helsinki University Hospital🇫🇮 Helsinki, Finland
University of Eastern Finland🇫🇮 Kuopio, Finland
Lahti Central Hospital🇫🇮 Lahti, Finland