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Probiotics for Cardiovascular Disease in HIV+ Individuals (META HIV CVD Trial)

Phase 2
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Not fluent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12 months

Summary

This trial will test if a pill containing healthy gut bacteria can reduce the risk of heart disease & death in people living with HIV who drink heavily.

Who is the study for?
This trial is for individuals living with HIV who are fluent in English. It's designed to help those who drink heavily and are at increased risk of heart disease and death due to changes in gut bacteria caused by alcohol.
What is being tested?
The study tests if a probiotic pill, which contains healthy gut bacteria, can boost the number of good bacteria in the gut, reduce inflammation, and lower heart disease risk compared to a placebo (a pill with no active ingredients).
What are the potential side effects?
Probiotics may cause digestive discomfort such as gas or bloating initially. However, they're generally considered safe with minimal side effects for most people.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not fluent in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Firmicutes to Bacteroidetes ratio
Secondary study objectives
Inflammation
Intestinal permeability
Microbial Translocation
Other study objectives
CVD risk
Mortality

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study SupplementExperimental Treatment1 Intervention
Probiotic
Group II: Study placeboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
901 Previous Clinical Trials
938,432 Total Patients Enrolled
University of LouisvilleOTHER
345 Previous Clinical Trials
77,165 Total Patients Enrolled
Boston UniversityOTHER
472 Previous Clinical Trials
9,987,576 Total Patients Enrolled
~129 spots leftby Feb 2026
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