RE and Probiotics in MAFLD/NAFLD

Prior treatment

• Participation in an interventional drug study within the last 3 months
• Individuals with any concomitant liver disease (viral hepatitis, drug-induced liver injury, metabolic/genetic diseases (e.g., Wilson's disease))
• Use of medications such as steroids, methotrexate, metformin
• Use of agents such as vitamin E, omega-3 fatty acids, or medications with evidence of an effect on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)
• Regular use of probiotic or prebiotic supplements within 3 months prior to study enrollment
• History of using an alternative diet within 3 months prior to study enrollment or changing diet during study entry
• Previous surgery (bariatric surgery, gastric or intestinal resection)
• Insulin therapy

Other illness

• Active or previous history of invasive cancer (excluding curatively treated carcinoma in situ \[e.g., cervical\] or benign skin cancer), unless complete remission has been achieved
• Known allergy to probiotics
• Uncontrolled diabetes
• Cardiovascular disease (e.g., uncontrolled blood pressure, coronary artery disease, NYHA class III-IV heart failure, severe arrhythmias, orthostatic intolerance)
• Nervous system disorders
• Cognitive impairment and dementia
• Active thyroid disease
• Cushing's syndrome
• Any implanted battery-powered device (e.g., AICD, pacemaker, cardiac rhythm recorder, cochlear implant)

Lab values

• 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

Other

• 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
• Participants with hepatic steatosis and regular alcohol consumption \> 30 g/day
• Parenteral nutrition (TPN) within the last 6 months
• Osteoporosis/osteopenia

• 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.

Criteria the registry did not label

• 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.