Precision Microbiota Interventions for Senoreduction Trial
Part of paid clinical trials in New Orleans, Louisiana.
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Study ID
- NCT07462767
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Aging
- Alcohol Drinking
- HIV Infections
- Immunosenescence
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Limosilactobacillus reuteri — DIETARY_SUPPLEMENTAdministered 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.
- Blueberry extract — DIETARY_SUPPLEMENTAdministered 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.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Dec 1, 2029
- Completion
- Dec 1, 2029
Study Design
- Enrollment
- 160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Sequence A: Probiotic then Blueberry ExtractParticipants receive probiotic for 4 weeks, washout 6 weeks, then blueberry extract for 4 weeks.
- Experimental: Sequence B: Blueberry Extract then ProbioticParticipants receive blueberry extract for 4 weeks, washout 6 weeks, then probiotic for 4 weeks.
Primary Outcome Measure
Change in circulating senescent T cell numbers [ Time Frame: Time 0 to Week 4 of treatment period ]
Central Contacts
- David A Welsh, MDUnited States
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| LSU Health | New Orleans | Louisiana | 70112 |
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