RecruitingEarly Phase 1NCT06113003

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


Sponsor

Vanderbilt University Medical Center

Enrollment

63 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how HIV infection and fatty liver disease (a buildup of fat in the liver) interact, and how the gut microbiome and body chemistry play a role. Researchers want to understand why people with HIV are more likely to develop liver problems. **You may be eligible if:** - You have one or more signs of metabolic syndrome (such as diabetes, high triglycerides, low good cholesterol, or high blood pressure) - OR you have been diagnosed with non-alcoholic fatty liver disease (NAFLD) - OR you have HIV and are on stable antiretroviral therapy **You may NOT be eligible if:** - You have other causes of liver disease (such as heavy alcohol use, hepatitis B or C, or certain medications that damage the liver) - You have had a liver transplant - You are pregnant - Specific additional medical or lab conditions identified at screening Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPrebiotic

Wheat dextrin fiber

DIETARY_SUPPLEMENTProbiotic

Probiotic packet


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT06113003


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