Recruiting
Phase 2

Microbiome Metabolites

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05288790

Conditions

Microtia

Dysbiosis

Alcohol Drinking

HIV Infections

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Probiotic

Placebo

Study Details

Brief 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

Microtia

Dysbiosis

Alcohol Drinking

HIV Infections

Cardiovascular Diseases

Study ID

NCT05288790

Start date

Sep 18, 2023

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • HIV infected

Exclusion Criteria:

  • Not fluent in English

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Supplement

Probiotic

placebo comparator: Study placebo

Placebo

Interventions

Probiotic

Dietary supplement

Placebo

Placebo sachet

Primary outcome measure

  • Firmicutes to Bacteroidetes ratio [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

David Crenshaw, MSW

615-322-7343

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-08-27.