Status:
NOT_YET_RECRUITING
RE and Probiotics in MAFLD/NAFLD
Lead Sponsor:
Nicolaus Copernicus University
Collaborating Sponsors:
Medical University of Warsaw
University of Oxford
Conditions:
NASH
NAFLD
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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) a...
Detailed Description
The human microbiome, understood here as the collective community of microorganisms, their genetic material, and metabolic products that colonize the body from birth, is particularly concentrated in t...
Eligibility Criteria
Inclusion
- • NAFLD/MAFLD or NASH diagnosis
Exclusion
- significant (structural) limitation of movement of the upper and/or lower limbs
- Not fluent in English or Polish
- Have participated in any trial or research project within 3 months
- history of following alternative diets within 3 months before the study or alternating diet during the trial,
- nervous system disorders
- cognitive function impairment and dementia
- pregnancy or nurturing
- significant (structural) limitation of movement of the upper and/or lower limbs
- osteoporosis/osteopenia
- unable to understand instructions
- receiving insulin
- unregulated diabetes
- stage 3 hypertension
- orthostatic intolerance
- chronic diseases of the cardiovascular system
- shift work
- those who will be found to have any concomitant liver disease
- Participants with liver steatosis and regular alcohol consumption of \> 30 g/day
- anticoagulants/antiplatelet therapy, immunosuppressants, antibiotics, corticosteroids, valproic acid, amiodarone, tamoxifen.Medication use of steroids, methotrexate, metformin. Use of agents such as vitamin E, omega-3 fatty acids, or medications with evidence for effects on NAFLD (pioglitazone, GLP-1 analogs, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)
- prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV infection with a CD4 count \< 240)
- active or prior history of invasive malignancy (except for curatively treated in situ carcinomas \[e.g., cervix\] or non-melanoma skin cancer) unless a complete remission was achieved
- previous surgery (bariatric, gastric, intestinal resection)
- parenteral nutrition (TPN) for the last 6 months
- active thyroid disorder
- Cushing's syndrome
- anticoagulant therapy
- antibiotics in the 3 months before inclusion
- regular use of a probiotic or prebiotic supplement within 3 months before enrollment;
- inclusion in a drug interventional trial in the previous 3 months
- Known allergy to probiotics
- Any implanted battery operated device (i.e. AICD, pacemaker, loop recorder, cochlear implant)
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2036
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06563921
Start Date
September 10 2024
End Date
September 10 2036
Last Update
August 21 2024
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