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Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

NCT05288790 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-06-24

No results posted yet for this study

Summary

Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic

Dietary supplement

DIETARY_SUPPLEMENT

Placebo

Placebo sachet

Sponsors & Collaborators

  • University of Louisville

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2026-08-28
Completion
2027-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05288790 on ClinicalTrials.gov