HIV InfectionsPhase 1/2PreMISNCT07462767
Precision Microbiota Interventions for Senoreduction Trial
A Phase 1/2 study testing Limosilactobacillus reuteri and Blueberry extract in people with HIV Infections and Alcohol Drinking, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HIV Infections, Alcohol Drinking, Aging
- What is being tested?
- Limosilactobacillus reuteri and Blueberry extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 years
- People with HIV
- Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)
Who cannot join
- Probiotic use in past 3 months
- Recent antibiotics or immunosuppressives
- Allergy to study products
- Pregnancy or breastfeeding
- Inability to comply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
LSU Health
New Orleans, Louisiana, 70112
David A Welsh, MD, United States ext. 5045684634, dwelsh@lsuhsc.edu
About this study
Official title: Geroprotective Precision Medicine Strategies in PWH That Use Alcohol
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.
Read the 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.
- Conditions
- HIV Infections, Alcohol Drinking, Aging, Immunosenescence
- Being tested
- Limosilactobacillus reuteri, Blueberry extract
- Keywords
- People with HIV, Alcohol use, Immunosenescence, Senescence, Microbiome, Probiotic, Blueberry extract, Crossover trial
- Medical subject headings
- HIV Infections, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limosilactobacillus reuteriDietary 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 extractDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Probiotic then Blueberry Extract | Experimental | Participants receive probiotic for 4 weeks, washout 6 weeks, then blueberry extract for 4 weeks. Receives: Dietary Supplement: Limosilactobacillus reuteri; Dietary Supplement: Blueberry extract |
| Sequence B: Blueberry Extract then Probiotic | Experimental | Participants receive blueberry extract for 4 weeks, washout 6 weeks, then probiotic for 4 weeks. Receives: Dietary Supplement: Limosilactobacillus reuteri; Dietary Supplement: Blueberry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time 0 to Week 4 of treatment period
Secondary outcomes (2)
Change in additional senescent T cell phenotypes
Flow cytometry-defined subsets
Measured: Baseline and Week 4
Change in epigenetic age estimation
Change in DNA methylation-based age estimates using epigenetic clock analyses.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Welsh, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- David A Welsh, MD, Principal investigator, LSU Health New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462767
- Sponsor's protocol ID
- 8883
- Acronym
- PreMIS
- Status last verified
- Sep 2026
- First submitted
- 22 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared upon reasonable request following publication, subject to data use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geroprotective Precision Medicine Strategies in PWH That Use Alcohol
- ClinicalTrials.gov ID
- NCT07462767
- Acronym / sponsor ID
- PreMIS / 8883
- Conditions
- HIV Infections, Alcohol Drinking, Aging, Immunosenescence
- Keywords
- People with HIV, Alcohol use, Immunosenescence, Senescence, Microbiome, Probiotic, Blueberry extract, Crossover trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Probiotic then Blueberry Extract | Experimental | Dietary Supplement: Limosilactobacillus reuteri, Dietary Supplement: Blueberry extractParticipants receive probiotic for 4 weeks, washout 6 weeks, then blueberry extract for 4 weeks. |
| Sequence B: Blueberry Extract then Probiotic | Experimental | Dietary Supplement: Limosilactobacillus reuteri, Dietary Supplement: Blueberry extractParticipants receive blueberry extract for 4 weeks, washout 6 weeks, then probiotic for 4 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥40 years
- People with HIV
- Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)
Key exclusion criteria (5 listed)
- Probiotic use in past 3 months
- Recent antibiotics or immunosuppressives
- Allergy to study products
- Pregnancy or breastfeeding
- Inability to comply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limosilactobacillus reuteriAdministered 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. | Dietary supplement | Sequence A: Probiotic then Blueberry Extract, Sequence B: Blueberry Extract then Probiotic |
| Blueberry extractAdministered 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. | Dietary supplement | Sequence A: Probiotic then Blueberry Extract, Sequence B: Blueberry Extract then Probiotic |
Primary outcome
Change in circulating senescent T cell numbers
Time frame: Time 0 to Week 4 of treatment period
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.
2 secondary outcomes
Change in additional senescent T cell phenotypes
Time frame: Baseline and Week 4
Change in epigenetic age estimation
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared upon reasonable request following publication, subject to data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David A Welsh, MD principal investigator
LSU Health New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Limosilactobacillus reuteri and Blueberry extract in people with HIV Infections and Alcohol Drinking, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David A Welsh, MD (United States ext. 5045684634, dwelsh@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating senescent T cell numbers (time frame: Time 0 to Week 4 of treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.