Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 89

Using probiotics to reduce heart disease risk in people with HIV who drink heavily

Official title: Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

Run by Vanderbilt University Medical Center · NCT05288790 · Data updated 2026-11-12

This study is testing if a probiotic pill can help improve gut health and lower heart disease risk in people with HIV who drink heavily.

More Cardiovascular Diseases trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 89 Years
SexAll
Enrollment250 (estimated)
SponsorVanderbilt University Medical Center
Academic / other
Locations1 site (Nashville, Tennessee)
StatusRecruiting
StartedSeptember 18, 2023
Main results expectedMarch 31, 2027
Study endsAugust 31, 2027
Registry record updatedAugust 27, 2026
Trial IDNCT05288790 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals living with HIV who engage in heavy alcohol consumption.

Probably not a fit

Patients who are not fluent in English or do not have HIV will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of a probiotic pill on gut health in individuals living with HIV who consume alcohol heavily. The study aims to determine if the probiotic can restore healthy gut bacteria, reduce inflammation, and lower the risk of cardiovascular disease and mortality. By focusing on the relationship between alcohol, gut dysbiosis, and heart health, the trial will assess changes in microbial profiles and inflammatory markers among participants. A total of 250 participants will be enrolled to evaluate the efficacy of the intervention compared to a placebo.

Why it matters

Potential benefit: If successful, this study could significantly lower the risk of heart disease and improve overall health outcomes for people living with HIV who consume alcohol.

How similar studies have gone: Previous studies have shown promising results with probiotics in improving gut health and reducing inflammation among similar populations, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* HIV infected

Exclusion Criteria:

* Not fluent in English

Where it's running

  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.