Exploring the link between HIV, liver health, and gut bacteria
The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease
This study is testing if adding prebiotic and probiotic fiber can help improve liver health in people living with HIV by looking at how gut bacteria might affect liver disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06113003 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between HIV and non-alcoholic fatty liver disease (NAFLD), focusing on how changes in the intestinal microbiome may contribute to liver disease in individuals with HIV. It aims to determine if supplementation with prebiotic and probiotic fiber can improve liver health markers in these patients. The research will analyze the gut microbiome and its metabolites to understand their role in liver disease progression among people living with HIV. By identifying these connections, the study seeks to provide insights into potential therapeutic interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals living with HIV who also have non-alcoholic fatty liver disease or components of metabolic syndrome.
Not a fit: Patients without HIV or those who do not have metabolic syndrome or NAFLD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary interventions that improve liver health in individuals with HIV.
How similar studies have performed: While there is limited data on this specific approach, studies have shown that gut microbiome alterations can impact liver health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 3-month interval
3. 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
Exclusion Criteria:
* 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
* 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Curtis L Gabriel, MD, PhD
- Email: curtis.L.gabriel@vumc.org
- Phone: 615-322-0128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.