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Recruiting Phase 2 NCT05288790

NCT05288790 Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

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Clinical Trial Summary
NCT ID NCT05288790
Status Recruiting
Phase Phase 2
Sponsor Vanderbilt University Medical Center
Condition Microtia
Study Type INTERVENTIONAL
Enrollment 250 participants
Start Date 2023-09-18
Primary Completion 2026-08-28

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 89 Years
Study Type INTERVENTIONAL
Interventions
ProbioticPlacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 250 participants in total. It began in 2023-09-18 with a primary completion date of 2026-08-28.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: * HIV infected Exclusion Criteria: * Not fluent in English

Contact & Investigator

Central Contact

Grace Wallace, BS

✉ grace.wallace@vumc.org

📞 615-936-5356

Frequently Asked Questions

Who can join the NCT05288790 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Microtia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT05288790 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT05288790 currently recruiting?

Yes, NCT05288790 is actively recruiting participants. Contact the research team at grace.wallace@vumc.org for enrollment information.

Where is the NCT05288790 trial being conducted?

This trial is being conducted at Nashville, United States.

Who is sponsoring the NCT05288790 clinical trial?

NCT05288790 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 250 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology