RE and Probiotics in MAFLD/NAFLD (NCT06563921) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RE and Probiotics in MAFLD/NAFLD
180 participantsStarted 2026-04-10
Plain-language summary
This project aims to evaluate the roles of the autonomic nervous system (ANS) and gut microbiota as correlates of clinical improvement in metabolic dysfunction-associated fatty liver disease (MAFLD) and non-alcoholic fatty liver disease (NAFLD) in response to a therapeutic regimen comprising resistance exercise and probiotic supplementation. The primary objective is to investigate the effects of these non-pharmacological interventions on MAFLD/NAFLD and to identify patient phenotypes based on baseline ANS profiles and gut microbiota composition that predict clinical responses.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Study population: Patients diagnosed with non-alcoholic or metabolically mediated fatty liver disease (NAFLD/MAFLD), including the inflammatory form (NASH), confirmed by imaging (ultrasound, MRI-PDFF) or histopathological (liver biopsy) methods.
Inclusion criteria:
* Diagnosis of NAFLD/MAFLD or NASH (imaging or histological confirmation of fatty liver disease, e.g., ultrasound, MRI-PDFF, biopsy)
* Age 18-60 years
* Ability to understand the study procedures and provide informed consent.
* Stable clinical condition for at least 3 months prior to study initiation.
Exclusion criteria:
* Lack of fluency in English or Polish
* Significant (structural) limitation of upper and/or lower limb mobility
* Pregnancy or breastfeeding
* Inability to understand instructions
* Shift work
* Participation in any study or research project within the last 3 months
* Participation in an interventional drug study within the last 3 months
* Participants with hepatic steatosis and regular alcohol consumption \> 30 g/day
* Individuals with any concomitant liver disease (viral hepatitis, drug-induced liver injury, metabolic/genetic diseases (e.g., Wilson's disease))
* Anticoagulant/antiplatelet therapy, antithrombotic therapy, immunosuppressive medications, prolonged immunosuppression (e.g., recent cytotoxic chemotherapy, HIV infection with CD4 count \< 240), antibiotics, corticosteroids, valproic acid, amiodarone, tamoxifen within 3 months prior to study enrollment
* Use of medications such as st…