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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12 months

Awards & highlights

META HIV CVD Trial 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.Check my eligibility

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).See study design

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.

META HIV CVD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Firmicutes to Bacteroidetes ratio

Inflammation

Intestinal permeability

+1 more

Other outcome measures

CVD risk

Mortality

META HIV CVD 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

671,943 Total Patients Enrolled

University of LouisvilleOTHER

339 Previous Clinical Trials

76,430 Total Patients Enrolled

Boston UniversityOTHER

455 Previous Clinical Trials

9,941,375 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research open to those beyond the age of 25?

"As per the stated criteria, participants must at least be 18 years of age and not exceed 89."

Answered by AI

What criteria must be met in order to enroll in this medical experiment?

"This cardiovascular disease study is recruiting 250 participants aged 18 to 89. Eligibility criteria stipulates that candidates must be HIV positive."

Answered by AI

Has the Study Supplement earned FDA authorization?

"As this is only a Phase 2 trial, our team at Power determined that Study Supplement's safety merits a score of two due to the presence of supporting data but lack thereof for efficacy."

Answered by AI

Are there any current openings for participants in this experiment?

"Affirmative. The data hosted on clinicaltrials.gov points to this study being actively recruiting at present, having first been posted on September 18th 2023 and last updated two days later. A total of 250 volunteers are required from one medical centre."

Answered by AI

What is the aggregate size of this research cohort?

"Affirmative. According to clinicaltrials.gov, this trial is actively searching for participants and was first posted on September 18th 2023 with a recent update occurring two days later. The study requires 250 individuals from one site to be enrolled in the research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

Matthew S.Freiberg 2023. "Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05288790.

All > Hiv Infection > Microbiome