Microbiome-Mediated Gut Dysfunction in Non-Alcoholic Fatty Liver Disease (NCT05209100) | Clinical Trial Compass
CompletedNot Applicable
Microbiome-Mediated Gut Dysfunction in Non-Alcoholic Fatty Liver Disease
United States38 participantsStarted 2022-02-11
Plain-language summary
This study is designed to generate the first human evidence to date on microbiota encroachment in non-alcoholic fatty liver disease. In parallel, the investigators will establish a biobank that will allow future studies to reveal how encroachment is connected to host metabolism and liver physiology, including the composition and function of the fecal microbiome.
Who can participate
Age range35 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 35-65 years
✓. Weight stable (weight change of no more than 3 kg + 0.5 kg) during the 6 months prior to enrollment
✓. Fasting triglycerides ≤400 mg/dL
✓. Body mass index (BMI) 27.5-39.9 kg/m2
✓. Able to speak and understand written and spoken English
✓. Understands the procedures and agrees to participate by giving written informed consent
✓. Willing and able to comply with scheduled visits, laboratory tests, and other study procedures
✓. Magnetic Resonance Imaging Proton Density Fat Fraction Criteria:
Exclusion criteria
✕. Diagnosis of type 1 or type 2 diabetes mellitus
✕. Insulin use
✕. Treatment with pioglitazone or metformin
✕. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within the previous 6 months (1 drink = 5 ounces \[150 mL\] of wine, 12 ounces \[360 mL\] of beer, or 1.5 ounces \[45 mL\] of hard liquor)
✕. A total score of ≥8 on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire, indicating harmful or hazardous alcohol consumption
What they're measuring
1
Microbiome Encroachment
Timeframe: Baseline
Trial details
NCT IDNCT05209100
SponsorAdventHealth Translational Research Institute