RECRUITING

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

Conditions

HIV Non-Alcoholic Fatty Liver Disease Metabolic-Associated Steatotic Liver Disease NAFLD MASLD Fiber Microbiome Probiotic Prebiotic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-18

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06113003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Curtis L Gabriel, MD, PhD

CONTACT

615-322-0128

curtis.L.gabriel@vumc.org

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18

Study Completion Date2025-07

Study Record Updates

Study Start Date2024-04-18

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

HIV
NAFLD
MASLD
Fiber
Microbiome
Probiotic
Prebiotic

Additional Relevant MeSH Terms

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