Microbiome Metabolites and Alcohol in HIV to Reduce Cardiovascular Disease Randomized Controlled Trial

What this Trial Is About

Researchers are investigating the effects of a probiotic supplement on people living with HIV who also consume alcohol heavily, as heavy drinking increases the risk of heart disease and death in this group. The study aims to understand if taking a pill containing healthy gut bacteria can increase beneficial gut bacteria, reduce inflammation, and lower the risk of heart disease and death. This is a randomized controlled trial focused on improving gut health and cardiovascular outcomes among HIV-positive individuals on antiretroviral therapy with sufficient immune cell counts. The trial compares two groups: one receiving a probiotic dietary supplement designed to counteract alcohol-related gut bacteria changes, and the other receiving a placebo. Both groups also receive counseling for alcohol use. The probiotic aims to improve gut bacteria balance, reduce harmful metabolites and inflammation, and ultimately decrease cardiovascular risk. The study measures these effects over a 6-month period, with additional assessments up to 12 months. Participants will be monitored through various tests including gut bacteria ratios, plasma metabolites, inflammation markers, and cardiovascular risk scores. The study also tracks alcohol consumption and HIV disease progression. Safety and adherence are assessed throughout the trial, and participants' health status is observed for up to a year. The findings will help determine if probiotics can be an effective adjunct therapy to improve health outcomes in this population.

Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT