Try a prebiotic supplement to support gut health alongside HIV treatment

Recruiting

What is this trial?

This trial is testing a prebiotic supplement—a special fiber that feeds healthy bacteria in your gut—in people living with HIV who are on effective antiretroviral therapy. Researchers believe that both HIV and alcohol use can damage the gut barrier and increase harmful inflammation in the body, even when HIV is well-controlled by medications. The medication may help restore gut health and reduce this inflammation.

People living with HIV often experience high levels of inflammation and related health problems, even when their HIV is well-controlled by treatment. Early research suggests that damage to the gut and loss of healthy bacteria may be driving this inflammation, especially in people who also struggle with alcohol use. This trial aims to test whether healing the gut with this treatment could reduce inflammation and improve overall health.

Do you qualify?

You likely qualify if…

you are between 21 and 75 years old
you have been diagnosed with HIV and have been on antiretroviral therapy for at least 12 months
your HIV is well-controlled, with an undetectable viral load for at least 6 months
you have a CD4+ T cell count above 250 cells/µl
you have a body mass index (BMI) between 25 and 40
for the alcohol use disorder group only: you score 4 or higher on a screening test for alcohol use (men) or 3 or higher (women)

You likely don't qualify if…

you have received a non-HIV vaccine in the past 30 days
you have an opportunistic infection or have had one in the past 30 days
you are taking immunosuppressive medications like steroids or cancer chemotherapy
you have serious liver disease (cirrhosis or elevated liver enzymes), kidney disease, uncontrolled diabetes, or heart failure
you have taken antibiotics in the past 4 weeks or are currently taking daily anti-inflammatory medications like ibuprofen more than 3 days per week
you are using herbal supplements, probiotics, or following restrictive diets (vegan, vegetarian, gluten-free, Paleo) that could affect your gut bacteria

What participation looks like

You will participate in this study for 8 weeks total. You'll visit the clinic in person 3 times and have 4 virtual check-ins. The study uses a crossover design, meaning you'll take the prebiotic supplement for 4 weeks, then switch to placebo (inactive pill) for 4 weeks—or vice versa, depending on which group you're randomly assigned to. This way, your own body serves as a comparison, helping researchers see how the medication actually affects you.

Testing a Gut-Healing Supplement in People With HIV and Alcohol Use

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)