A Phase 1/2 interventional study of Limosilactobacillus reuteri and Blueberry extract in HIV Infections, Alcohol Drinking and Aging, sponsored by Louisiana State University Health Sciences Center in New Orleans. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Phase 1/2, Interventional, and Basic science
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 160 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 72 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive probiotic for 4 weeks, washout 6 weeks, then blueberry extract for 4 weeks.
Dietary Supplement: Limosilactobacillus reuteri · Dietary Supplement: Blueberry extract
Participants receive blueberry extract for 4 weeks, washout 6 weeks, then probiotic for 4 weeks.
Dietary Supplement: Limosilactobacillus reuteri · Dietary Supplement: Blueberry extract
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.
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.
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 frame: Time 0 to Week 4 of treatment period
Change in additional senescent T cell phenotypes
Flow cytometry-defined subsets
Time frame: Baseline and Week 4
Change in epigenetic age estimation
Change in DNA methylation-based age estimates using epigenetic clock analyses.
Time frame: Baseline and Week 4
Change in additional senescent T cell phenotypes
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.
Time frame: time 0 to 4 weeks
Microbiome and metabolite profiles
Stool microbiome (phylogenetic analysis and bacterial genes quantification) and metabolite analyses.
Time frame: Baseline and Week 4
Plan to share: Yes — De-identified individual participant data will be shared upon reasonable request following publication, subject to data use agreements.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Lactobacillus reuteri · Blueberry extract
Louisiana State University Health Sciences Center in New Orleans