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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | September 18, 2023 |
| Main results expected | March 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT05288790 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
- Study coordinator: Grace Wallace, BS
- Email: grace.wallace@vumc.org
- Phone: 615-936-5356
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.