Recruiting
Phase 1
Phase 2

Microbiota Interventions

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT07462767

Conditions

HIV Infections

Alcohol Drinking

Aging

Immunosenescence

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Limosilactobacillus reuteri

Blueberry extract

Study Details

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.

Conditions

HIV Infections

Alcohol Drinking

Aging

Immunosenescence

Study ID

NCT07462767

Start date

Sep 1, 2026

Status verified date

Oct, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Sequence A: Probiotic then Blueberry Extract

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

experimental: Sequence B: Blueberry Extract then Probiotic

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

Interventions

Limosilactobacillus reuteri

Administered as 8 capsules daily (4 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

Administered as 8 capsules daily (4 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 outcome measure

  • Change in circulating senescent T cell numbers [ Time Frame: Time 0 to Week 4 of treatment period ]

Central Contacts and Locations

Central contacts

David A Welsh, MD

United Statesdwelsh@lsuhsc.edu

Locations

LSU Health

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

David A Welsh, MD

United Statesdwelsh@lsuhsc.edu

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • People with HIV
  • Alcohol use
  • Immunosenescence
  • Senescence
  • Microbiome
  • Probiotic
  • Blueberry extract
  • Crossover trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.