← Back to Clinical Trials
Recruiting EARLY_Phase 1 NCT06113003

The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease

Trial Parameters

Condition HIV
Sponsor Vanderbilt University Medical Center
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 63
Sex ALL
Min Age 18 Years
Max Age 89 Years
Start Date 2024-04-18
Completion 2026-03-01
Interventions
PrebioticProbiotic

Brief Summary

Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH.

Eligibility Criteria

Inclusion Criteria: * One of the following: 1. One or more of the components of metabolic syndrome, defined as: 1. Diagnosis of diabetes: on medication for diabetes for at least 6 months, HbA1c \>6.5%, or fasting glucose \>99 mg/dL 2. Elevated fasting triglycerides: \>149 mg/dL or on medication for dyslipidemia 3. Reduced HDL-C: \<40 mg/dL in males, \<50 mg/dL in females or on medication for dyslipidemia 4. Elevated blood pressure: \>129 mm Hg systolic and/or \>84 mm Hg diastolic or on medication for hypertension 5. Prior diagnosis of hepatic steatosis or NAFLD: hepatic steatosis noted on interpretation of clinical imaging, CT scan liver density of less than 58 HU, Fibroscan CAP score \>238 dB/m, MRI-PDFF ≥5%, liver biopsy showing ≥5% triglyceride content 2. Persistently abnormal transaminases: elevated liver enzymes defined by transaminases ≥1.5 upper limit of normal (\[ULN\] = 35 IU/mL) and/or gammaglutamyltransferase level ≥2 ULN (ULN = 60 IU/L) on 2 blood samples within at least a

Related Trials