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

NCT06113003 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: 231185
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Non-Alcoholic Fatty Liver Disease; Metabolic-Associated Steatotic Liver Disease

Keywords

HIV; NAFLD; MASLD; Fiber; Microbiome; Probiotic; Prebiotic

Outcome Measures

Primary Outcomes (1)

• Plasma phosphatidylcholine

  Plasma phosphatidylcholine abundance is measured

  24 weeks

Secondary Outcomes (7)

• Proton Density Fat Fraction

  24 weeks

• Simpson Index

  24 weeks

• Soluble CD14

  24 weeks

• Fatty Acid Binding Protein

  24 weeks

• CD163

  24 weeks

Study Arms (1)

Probiotic and Prebiotic Fiber

EXPERIMENTAL

Dietary Supplement: Prebiotic; Dietary Supplement: Probiotic

Interventions

Prebiotic DIETARY_SUPPLEMENT

Wheat dextrin fiber

Probiotic and Prebiotic Fiber

Probiotic DIETARY_SUPPLEMENT

Probiotic packet

Probiotic and Prebiotic Fiber

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One of the following:
• One or more of the components of metabolic syndrome, defined as:
• Diagnosis of diabetes: on medication for diabetes for at least 6 months, HbA1c \>6.5%, or fasting glucose \>99 mg/dL
• Elevated fasting triglycerides: \>149 mg/dL or on medication for dyslipidemia
• Reduced HDL-C: \<40 mg/dL in males, \<50 mg/dL in females or on medication for dyslipidemia
• Elevated blood pressure: \>129 mm Hg systolic and/or \>84 mm Hg diastolic or on medication for hypertension
• 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
• 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 3-month interval
• BMI ≥ 30 kg/m2
• Documented HIV infection
• On antiretroviral therapy for at least 18 months
• HIV-1 RNA \<50 copies/ml for the prior 12 months
• CD4 count \>350 cells/microliter for the prior 12 months
• Ability to be contacted by phone (home or cell)
• Access to a private (i.e. accessible only to participant and immediate family or roommates) refrigerator for 6 months

You may not qualify if:

• Not fluent in English
• Known allergy to the study product or its formulation
• Pregnant or planning to become pregnant within the next six months
• History of chronic diarrhea in the past three months
• Breastfeeding
• History of celiac disease
• Prior diagnosis of non-NAFLD liver disease including, but not limited to, Wilson Disease, hemochromatosis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, and alpha 1 antitrypsin deficiency
• On medications associated with secondary NAFLD including systemic corticosteroids, tamoxifen, methotrexate, nifedipine, history of cancer chemotherapy,
• Positive hepatitis C quant or on treatment for hepatitis C within the last 12 months
• History of cirrhosis or liver transplant
• AUDIT-C score ≥3 women and ≥4 in men
• History of inflammatory bowel disease
• History of all other GI surgery within the past 12 months
• Use of antibiotics in the past 30 days
• Metal shrapnel, MRI incompatible hardware or claustrophobia that would preclude MRI imaging

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Prebiotics; Probiotics

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Pre/Post Trial

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 2, 2023
• Study Start: April 18, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)