← Back to Search

Probiotic + Prebiotic for Fatty Liver in HIV/AIDS (GLAM HIV NAFLD Trial)

Q: Are there opportunities to enroll in this trial?

Based on the information presented on clinicaltrials.gov, this trial is not currently recruiting participants. First posted in December of 2023 and last updated October 30th 2023, 1006 other studies are actively seeking patients at this time.

Q: Are individuals aged sixty or above qualified to participate in this test?

Patients that are aged 18 or over, and not beyond 89 years old may enroll in this medical trial.

Q: What qualifications do potential participants need to meet in order to join this medical experiment?

In order to meet the qualifications for this research, potential participants should have <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>/<a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> and be between 18-89 years old. Approximately 63 people will take part in this trial.

Phase 1 & 2

Waitlist Available

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of diabetes: on medication for diabetes for at least 6 months, HbA1c >6.5%, or fasting glucose >99 mg/dL

Reduced HDL-C: <40 mg/dL in males, <50 mg/dL in females or on medication for dyslipidemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

GLAM HIV NAFLD Trial Summary

This trial will explore if changes in the gut microbiome are linked to fatty liver in people with HIV and if probiotics & fiber can help improve it.

Who is the study for?

This trial is for adults with HIV who have high triglycerides, signs of metabolic syndrome, or a diagnosis of fatty liver disease. They must be on stable antiretroviral therapy with controlled HIV and not pregnant, planning pregnancy, or have other liver diseases. Participants need to speak English and have access to a private fridge.Check my eligibility

What is being tested?

The study investigates if probiotics and prebiotics can improve markers of fatty liver disease in people with HIV by altering the gut microbiome. It's testing whether these supplements can help maintain a healthy gut-liver relationship.See study design

What are the potential side effects?

Probiotics and prebiotics are generally considered safe but may cause digestive discomfort such as bloating, gas, or changes in bowel movements for some individuals.

GLAM HIV NAFLD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been on diabetes medication for over 6 months with high blood sugar levels.

Select...

My HDL cholesterol is low or I am on medication for dyslipidemia.

Select...

My blood pressure is high or I am on medication for it.

Select...

I have been diagnosed with fatty liver disease based on tests or imaging.

Select...

My fasting triglycerides are high or I am on medication for dyslipidemia.

GLAM HIV NAFLD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plasma phosphatidylcholine

Secondary outcome measures

CD163

Fatty Acid Binding Protein

Firmicutes-to-Bacteroidetes Ratio

+4 more

GLAM HIV NAFLD Trial Design

1Treatment groups

Experimental Treatment

Group I: Probiotic and Prebiotic FiberExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic

2013

Completed Phase 4

~3570

Prebiotic

2016

Completed Phase 2

~720

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,129 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to enroll in this trial?

"Based on the information presented on clinicaltrials.gov, this trial is not currently recruiting participants. First posted in December of 2023 and last updated October 30th 2023, 1006 other studies are actively seeking patients at this time."

Answered by AI

Are individuals aged sixty or above qualified to participate in this test?

"Patients that are aged 18 or over, and not beyond 89 years old may enroll in this medical trial."

Answered by AI

What qualifications do potential participants need to meet in order to join this medical experiment?

"In order to meet the qualifications for this research, potential participants should have HIV/AIDS and be between 18-89 years old. Approximately 63 people will take part in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Curtis Gabriel 2024. "The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06113003.

All > Fatty Liver Disease > Hiv