Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

ConditionsMicrotia Dysbiosis Alcohol Drinking HIV Infections Cardiovascular Diseases

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-89

SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HIV infected

Disqualifiers

Not fluent in English

Trial design

Design model

Parallel

Treatments tested in this trial

Probiotic
Dietary supplement
Dietary supplement
Placebo
Dietary supplement
Placebo sachet

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Study SupplementExperimental treatment 1 intervention

Group B: Study placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Firmicutes to Bacteroidetes ratio

Dysbiosis

Time frame

6 months

Secondary outcomes

Intestinal permeability

measuring levels of butyrate, deoxycholic acid:cholic acid ratio, and TMAO

Time frame

6, 12 months

Firmicutes to Bacteroidetes ratio

Dysbiosis measurement

Time frame

12 months

Microbial Translocation

measuring plasma lipopolysaccharide binding protein

Time frame

6, 12 months

Inflammation

measuring plasma for interleukin 6 \[IL-6\], D-dimer, and sCD14

Time frame

6, 12 months

Other outcomes

Mortality

Veterans Aging Cohort Study Index Score (lower scores are better and higher scores are worse) (ranges from 0-164)

Time frame

6 and 12 months

CVD risk

Reynolds Risk Score (the higher the score the higher the risk) (ranges from 100-400 mg/dL)

Time frame

6 and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

University of Louisville

Collaborator

Boston University

Collaborator

Source ClinicalTrials.gov

Apply now