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Precision Microbiota Interventions for Senoreduction Trial

ConditionsHIV InfectionsAlcohol DrinkingAgingImmunosenescence
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorLouisiana State University Health Sciences Center in New Orleans

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥40 years

People with HIV

Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)

Disqualifiers

Probiotic use in past 3 months

Recent antibiotics or immunosuppressives

Allergy to study products

Pregnancy or breastfeeding

Trial design

Design model

Crossover

Treatments tested in this trial

  • Limosilactobacillus reuteri

    Dietary supplement

    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

    Dietary supplement

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Sequence A: Probiotic then Blueberry ExtractExperimental treatment 2 interventions
Group B: Sequence B: Blueberry Extract then ProbioticExperimental treatment 2 interventions

Trial outcomes

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 frame
Time 0 to Week 4 of treatment period

Secondary outcomes

1

Change in additional senescent T cell phenotypes

Flow cytometry-defined subsets

Time frame
Baseline and Week 4
2

Change in epigenetic age estimation

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

Time frame
Baseline and Week 4

Other outcomes

1

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
2

Microbiome and metabolite profiles

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

Time frame
Baseline and Week 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Louisiana State University Health Sciences Center in New Orleans

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: