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NCT Number: NCT07462767

Precision Microbiota Interventions for Senoreduction Trial

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.

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Key information

Conditions

HIV Infections Aging Alcohol Drinking Behavior Blood-Borne Infections Communicable Diseases Drinking Behavior Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Immunosenescence Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

LSU Health

New Orleans, Louisiana, 70112, United States

Location contact

David A Welsh, MD

CONTACT

[email protected]

United States ext. 5045684634

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥40 years
  • People with HIV
  • Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)

Exclusion criteria

  • Probiotic use in past 3 months
  • Recent antibiotics or immunosuppressives
  • Allergy to study products
  • Pregnancy or breastfeeding
  • Inability to comply

Treatment and study plan

Limosilactobacillus reuteri

Dietary Supplement

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.

Blueberry extract

Dietary Supplement

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.

Primary outcomes

  1. Change in circulating senescent T cell numbers

    Time frame: Time 0 to Week 4 of treatment period

    Change in circulating CD3+CD8+CD28-CD38+ T cell count (cells/µL) during treatment period. Measured by multiparameter flow cytometry. The primary endpoint is the within-participant difference in change from baseline.

Secondary outcomes

  1. Change in additional senescent T cell phenotypes

    Time frame: Baseline and Week 4

    Flow cytometry-defined subsets

  2. Change in epigenetic age estimation

    Time frame: Baseline and Week 4

    Change in DNA methylation-based age estimates using epigenetic clock analyses.

Other outcomes

  1. Change in additional senescent T cell phenotypes

    Time frame: time 0 to 4 weeks

    Exploratory analyses of additional T cell phenotypes including assess additional senescence markers including lysosomal-β-galactosidase (GLB1), proinflammatory SASP (IL-1β, IL-2, IL17A, IL-18, TNFa, IFNg, HMBG1), proliferation (Ki67), CD27, CD57, and DNA damage (p-H2A.X) in T cells at multiple stages of maturation including naïve, effector, memory, and TEMRA.

  2. Microbiome and metabolite profiles

    Time frame: Baseline and Week 4

    Stool microbiome (phylogenetic analysis and bacterial genes quantification) and metabolite analyses.

Study contacts

Contact information is provided by the study sponsor or research team.

David A Welsh, MD

CONTACT

[email protected]

United States ext. 5045684634

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

Geroprotective Precision Medicine Strategies in PWH That Use Alcohol

Acronym: PreMIS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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