NCT05607745Active, not recruiting
Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study
Dietary Counseling Coupled With Fecal Microbiota Transplantation in the Treatment of Obesity and Non-alcoholic Fatty Liver Disease - the DIFTOB Study
Source: ClinicalTrials.gov · Last updated 7 Nov 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 2 Nov 2022
- Start date
- 30 Oct 2022
- Primary completion date
- Jun 2024
- Lead sponsor
- University of Eastern Finland
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05607745
What you commit to
- Study type: Interventional
- Planned participants: 54
- From 30 Oct 2022 to the primary completion date, Jun 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Procedures that have changed the anatomy of GI-tract, including obesity surgery
- Systemic antibacterial treatments
- three months before the study or during the study
- chronic or recurrent bacterial infection for which antimicrobial medications are repeatedly used
- Medications for losing weight (bupropion/naltrexon, orlistat, liraglutide)
- Intention to obesity surgery.
- Eligibility is evaluated by a doctor in each research unit.
Other illness
- Type I diabetes
- Inflammatory disease
- Liver disease other than NAFLD
- 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%)
- Remarkable psychiatric disorders, dementia and other diseases or conditions that could affect to the study subject´s compliance to the study
Other
- Unable to provide written consent
- Attending another trial or having on-going dietary counseling at the same time
- Pregnancy, breast feeding
- 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
- Contraindication for gastroscopy
- Central anesthesia needed for gastroscopy
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| University Of Eastern Finland Coordinator of this site? Confirm its status | Kuopio | Finland | Unknown status |
| Lahti Central Hospital Coordinator of this site? Confirm its status | Lahti | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.