NCT07462767

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
42mo left

Started Apr 2026

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2029

First Submitted

Initial submission to the registry

February 22, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

February 22, 2026

Last Update Submit

March 5, 2026

Conditions

HIV InfectionsAlcohol DrinkingAgingImmunosenescence

Keywords

People with HIVAlcohol useImmunosenescenceSenescenceMicrobiomeProbioticBlueberry extractCrossover trial

Outcome Measures

Primary Outcomes (1)

  • Change in circulating senescent T cell numbers

    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.

    Time 0 to Week 4 of treatment period

Secondary Outcomes (2)

  • Change in additional senescent T cell phenotypes

    Baseline and Week 4

  • Change in epigenetic age estimation

    Baseline and Week 4

Other Outcomes (2)

  • Change in additional senescent T cell phenotypes

    time 0 to 4 weeks

  • Microbiome and metabolite profiles

    Baseline and Week 4

Study Arms (2)

Sequence A: Probiotic then Blueberry Extract

EXPERIMENTAL

Participants receive probiotic for 4 weeks, washout 6 weeks, then blueberry extract for 4 weeks.

Dietary Supplement: Limosilactobacillus reuteriDietary Supplement: Blueberry extract

Sequence B: Blueberry Extract then Probiotic

EXPERIMENTAL

Participants receive blueberry extract for 4 weeks, washout 6 weeks, then probiotic for 4 weeks.

Dietary Supplement: Limosilactobacillus reuteriDietary Supplement: Blueberry extract

Interventions

Limosilactobacillus reuteriDIETARY_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.

Sequence A: Probiotic then Blueberry ExtractSequence B: Blueberry Extract then Probiotic
Blueberry extractDIETARY_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.

Sequence A: Probiotic then Blueberry ExtractSequence B: Blueberry Extract then Probiotic

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU Health

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

HIV InfectionsAlcohol Drinking

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDrinking BehaviorBehavior

Study Officials

  • David A Welsh, MD

    LSU Health New Orleans

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Welsh, MD

CONTACT

United Statesdwelsh@lsuhsc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Investigator)
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2026

First Posted

March 10, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be shared upon reasonable request following publication, subject to data use agreements.

Locations

US(1)