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HIVEarly Phase 1GLAM HIV NAFLDNCT06113003

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

A Early Phase 1 study testing Prebiotic and Probiotic in people with HIV and Non-Alcoholic Fatty Liver Disease, run by Vanderbilt University Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
What is being tested?
Prebiotic and Probiotic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteUnited States
Study dates
18 Apr 2024to 1 Jun 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Able and willing to comply with all study protocols and procedures

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Inability to participate in the study in the opinion of the participant's HIV treatment provider
  • Use of prebiotic(s) including fiber supplements and/or probiotic(s) within the past 90 days
  • Participant has history of hemicolectomy, colectomy, small bowel resection, bariatric surgery, gastric bypass surgery, or short bowel syndrome

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

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.

Read the detailed description

Over 1.1 million people in the United States are living with human immunodeficiency virus (HIV). Liver disease is a leading cause of mortality in persons with HIV (PWH), and PWH suffer a disproportionate burden of non-alcoholic fatty liver disease (NAFLD). While the mechanisms underlying this disparity are not well understood, harmful changes in the intestinal microbiome ("dysbiosis") and increased bacterial product movement across the intestinal lining ("leaky gut") are implicated in the pathogenesis of NAFLD in HIV-negative persons. HIV infection has been shown to alter the intestinal microbiome and promote leaky gut; however, there are few data on the microbiome among PWH with NAFLD. Our overarching hypothesis is that intestinal dysbiosis in PWH promotes NAFLD through: 1) impairment of the barrier function of the intestinal lining causing translocation of proinflammatory bacterial products to the bloodstream and 2) alteration of plasma metabolites that promote NAFLD. Specifically, HIV-associated gut dysbiosis leads to reduction in the production of short chain fatty acids, which are essential for the maintenance of a healthy intestinal lining. A reduction in butyrate production leads to breakdown of the intestinal barrier, allowing for translocation of inflammatory bacterial products into the splanchnic vasculature and the liver. These products lead to inflammation and disruption of lipid metabolism in the liver causing lipid deposition in the liver. Additionally, dysbiosis in PWH leads to lower bacterial production of lipids necessary for fat metabolism in the liver leading to NAFLD. We will test these hypotheses in a single arm pre/post feasibility and efficacy trial of an intervention designed to restore a healthy gut microbiome in PWH with NAFLD (n=63). The study will assess the effects of a probiotic containing multiple strains of bacteria supporting butyrate synthesis and prebiotic fiber among PWH at risk of NAFLD (diagnosis of metabolic syndrome, elevated BMI or elevated transaminases) without history of current excessive alcohol use, viral hepatitis or other known liver diseases.

Being tested
Prebiotic, Probiotic
Keywords
HIV, NAFLD, MASLD, Fiber, Microbiome, Probiotic, Prebiotic
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrebioticDietary supplement

    Wheat dextrin fiber

  • ProbioticDietary supplement

    Probiotic packet

Study groups in NCT06113003
Study groupRoleWhat they receive
Probiotic and Prebiotic FiberExperimentalNot described
Receives: Dietary Supplement: Prebiotic; Dietary Supplement: Probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma phosphatidylcholine

    Plasma phosphatidylcholine abundance is measured

    Measured: 24 weeks

Secondary outcomes (7)

  1. Proton Density Fat Fraction

    Hepatic steatosis is measured using magnetic resonance imaging proton density fat fraction

    Measured: 24 weeks

  2. Simpson Index

    The Simpson Index is a measure of intestinal bacterial diversity.

    Measured: 24 weeks

  3. Soluble CD14

    Soluble CD14 is an indirect plasma markers of intestinal barrier function

    Measured: 24 weeks

  4. Fatty Acid Binding Protein

    Fatty acid binding protein is an indirect plasma markers of intestinal barrier function

    Measured: 24 weeks

  5. CD163

    CD163 is an indirect plasma markers of intestinal barrier function

    Measured: 24 weeks

  6. Firmicutes-to-Bacteroidetes Ratio

    The Firmicutes-to-Bacteroidetes ratio is a measure of intestinal bacterial diversity.

    Measured: 24 weeks

  7. Shannon Index

    The Shannon Index is a measure of intestinal bacterial diversity.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start18 Apr 2024
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pre/Post Trial
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06113003
Sponsor's protocol ID
231185
Acronym
GLAM HIV NAFLD
Status last verified
Apr 2026
First submitted
24 Oct 2023
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share IPD outside of VUMC study team.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Prebiotic and Probiotic in people with HIV and Non-Alcoholic Fatty Liver Disease, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma phosphatidylcholine (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06113003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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