Probiotics to improve gut health and lower heart disease risk in people with HIV who drink alcohol

Microbiome, metabolites, and alcohol in HIV to reduce CVD RCT (META HIV CVD RCT)

NIH-funded research Vanderbilt University Medical Center · NIH-11169835

This project sees if a daily probiotic helps people with HIV who drink heavily by improving gut bacteria, cutting harmful gut chemicals like TMAO, and lowering inflammation that can raise heart disease risk.

Quick facts

Grant typeP01 program project
Study typeNIH-funded research
Funding institutionVanderbilt University Medical Center NIH-funded
Lab location1 site (Nashville, United States)
Project IDNIH-11169835 on NIH RePORTER

What this research studies

You would join if you are living with HIV, on antiretroviral therapy, and drink heavily. Participants are randomized in a clinical trial to receive a probiotic or comparison over a planned treatment period, with regular clinic visits for blood tests and stool samples to measure gut bacteria, microbial products, and inflammation. The team will track changes in harmful metabolites such as TMAO and markers of microbial translocation, and link those measures to future heart disease risk and mortality. The project builds on earlier pilot work at the same centers and enrolls about 250 people to get clearer answers.

Who could benefit from this research

Good fit: Ideal candidates are adults living with HIV who are on antiretroviral therapy, report heavy alcohol use, and are willing to attend clinic visits and provide blood and stool samples.

Not a fit: People who do not drink heavily, are not living with HIV, or have medical reasons they cannot take probiotics are unlikely to benefit from this specific project.

Why it matters

Potential benefit: If successful, the probiotic could improve gut health, lower harmful gut-derived chemicals and inflammation, and potentially reduce heart disease risk in people with HIV who drink heavily.

How similar studies have performed: Small pilot studies in people with HIV suggest probiotics are safe and may improve gut dysbiosis and inflammation, but using them to lower TMAO or prevent heart disease is still unproven.

Where this research is happening

Nashville, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Acquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome Virus
Last reviewed 2026-06-10 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.