NCT07462767

Precision Microbiota Interventions for Senoreduction Trial

Geroprotective Precision Medicine Strategies in PWH That Use Alcohol

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

People with HIV who drink alcohol are at increased risk for accelerated aging biology, including increased immune senescence. This randomized, double-blind, crossover clinical trial evaluates two generally recognized as safe (GRAS) microbiota-targeted interventions on immune senescence biomarkers.

Detailed description

This is a randomized, double-blind, controlled, crossover mechanistic clinical trial in people with HIV who have recent alcohol use. Participants are randomized to receive either Limosilactobacillus reuteri probiotic or blueberry extract first for 4 weeks, followed by a 6-week washout period, then crossover to the alternate intervention for 4 weeks. Each participant receives both interventions. Both interventions are generally recognized as safe (GRAS) dietary supplements and are not intended to diagnose, treat, cure, or prevent disease. This study is not conducted under an Investigational New Drug (IND) application and does not involve FDA-regulated investigational products. Biospecimen collection and clinical assessments are performed at baseline and Week 4 of each intervention period. The primary analysis compares within-participant changes in immune senescence markers between interventions using a crossover design framework and accounts for period and sequence effects. Participants will be recruited from HIV clinical care programs, affiliated clinics, and community outreach efforts in the New Orleans area. A 6-week washout period is included to minimize potential carryover effects.

Conditions

• HIV Infections
• Alcohol Drinking
• Aging
• Immunosenescence

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Limosilactobacillus reuteri	Administered as 6 capsules daily (3 twice daily) for 4 weeks. Each daily dose contains 1×10\^10 CFU total in a 1:1 ratio of two strains. This is a GRAS dietary supplement and not an FDA-regulated investigational product.
DIETARY_SUPPLEMENT	Blueberry extract	Administered as 6 capsules daily (3 twice daily) for 4 weeks, providing 500 mg anthocyanins per day. This is a GRAS dietary supplement and not an FDA-regulated investigational product.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States