Microbiome-Mediated Gut Dysfunction in Non-Alcoholic Fatty Liver Disease

Completed

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT05209100

Run by

AdventHealth Translational Research Institute

People needed

38

Starts

2022-02-11

Expected to finish

2023-03-22

Last updated by the study team

2026-04-03

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Controls: <5%
• Steatosis Only: ≥5.6%
• Fibrosis: no specific percentage required
• Magnetic Resonance Elastography Criteria:
• Controls: < 2.50 kPa
• Steatosis Only: <2.50 kPa
• Fibrosis (without cirrhosis): >2.61 - < 4.69 kPa

You may not qualify if…

• Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to:
• 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
• Clinical evidence of hepatic decompensation, including, but not limited to esophageal varices, ascites, or hepatic encephalopathy.
• Evidence of other forms of chronic liver disease (including laboratory tests and confirmed with a single repeat, if needed):
• Hepatitis B virus: defined by presence of hepatitis B surface antigen
• Hepatitis C virus: As defined by a clinical history of previous diagnosis of Hepatitis C (treated or untreated) or a positive Hepatitis C antibody.
• Known diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndrome
• Alcoholic liver disease
• Known diagnosis of hemochromatosis
• Prior known drug-induced liver injury
• Known or suspected hepatocellular carcinoma or other liver cancer
• History of liver transplant, current placement on a liver transplant list, or current model of end-stage liver disease (MELD) score >12
• Histological presence of cirrhosis on a prior biopsy
• Bleeding disorders
• Current treatment of blood thinners or antiplatelet medications that cannot be safely stopped for biopsy procedure.
• Acute or chronic infections
• Severe asthma or chronic obstructive pulmonary disease
• Renal insufficiency or nephritis
• Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
• Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
• Prior or planned bariatric surgery

Where it is running

• AdventHealth Translational Research Institute — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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