Precision Microbiota Interventions for Senoreduction Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Limosilactobacillus reuteri, Blueberry extract.
- Who it may be relevant to
- Registry conditions: HIV Infections, Alcohol Drinking, Aging, Immunosenescence. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Geroprotective Precision Medicine Strategies in PWH That Use Alcohol
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Limosilactobacillus reuteri
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. - Dietary supplement Blueberry extract
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 outcome measures
- Change in circulating senescent T cell numbers [Time frame: Time 0 to Week 4 of treatment period]
Secondary outcome measures (2)
- Change in additional senescent T cell phenotypes [Time frame: Baseline and Week 4]
- Change in epigenetic age estimation [Time frame: Baseline and Week 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- LSU Health — New Orleans
Identifiers
NCT: NCT07462767 · 8883