Using probiotics to reduce heart disease risk in people with HIV who drink heavily
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
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 |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05288790 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals living with HIV who engage in heavy alcohol consumption.
Not a fit: Patients who are not fluent in English or do not have HIV will not benefit from this study.
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 performed: Previous studies have shown promising results with probiotics in improving gut health and reducing inflammation among similar populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV infected Exclusion Criteria: * Not fluent in English
Where this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.