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

Phase 1 & 2
Recruiting
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
Must not have
Not fluent in English
History of chronic diarrhea in the past three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on diabetes medication for over 6 months with high blood sugar levels.
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My HDL cholesterol is low or I am on medication for dyslipidemia.
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My blood pressure is high or I am on medication for it.
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I have been diagnosed with fatty liver disease based on tests or imaging.
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My fasting triglycerides are high or I am on medication for dyslipidemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not fluent in English.
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I have had chronic diarrhea for the last three months.
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I have been diagnosed with celiac disease.
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I have been diagnosed with a liver disease other than NAFLD.
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I have had cirrhosis or a liver transplant.
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I have a history of inflammatory bowel disease.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Plasma phosphatidylcholine
Secondary study objectives
CD163
Fatty Acid Binding Protein
Firmicutes-to-Bacteroidetes Ratio
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~800

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
901 Previous Clinical Trials
938,619 Total Patients Enrolled
~26 spots leftby May 2025
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