Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:38 AM
Study NCT ID:
NCT07462767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Microbiota Interventions for Senoreduction Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721609', 'term': 'blueberry extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double (Participant, Investigator)'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in additional senescent T cell phenotypes', 'timeFrame': 'time 0 to 4 weeks', 'description': '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.'}, {'measure': 'Microbiome and metabolite profiles', 'timeFrame': 'Baseline and Week 4', 'description': 'Stool microbiome (phylogenetic analysis and bacterial genes quantification) and metabolite analyses.'}], 'primaryOutcomes': [{'measure': 'Change in circulating senescent T cell numbers', 'timeFrame': 'Time 0 to Week 4 of treatment period', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in additional senescent T cell phenotypes', 'timeFrame': 'Baseline and Week 4', 'description': 'Flow cytometry-defined subsets'}, {'measure': 'Change in epigenetic age estimation', 'timeFrame': 'Baseline and Week 4', 'description': 'Change in DNA methylation-based age estimates using epigenetic clock analyses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['People with HIV', 'Alcohol use', 'Immunosenescence', 'Senescence', 'Microbiome', 'Probiotic', 'Blueberry extract', 'Crossover trial'], 'conditions': ['HIV Infections', 'Alcohol Drinking', 'Aging', 'Immunosenescence']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBoth 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.\n\nBiospecimen 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.\n\nParticipants will be recruited from HIV clinical care programs, affiliated clinics, and community outreach efforts in the New Orleans area.\n\nA 6-week washout period is included to minimize potential carryover effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥40 years\n* People with HIV\n* Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)\n\nExclusion Criteria:\n\n* Probiotic use in past 3 months\n* Recent antibiotics or immunosuppressives\n* Allergy to study products\n* Pregnancy or breastfeeding\n* Inability to comply'}, 'identificationModule': {'nctId': 'NCT07462767', 'acronym': 'PreMIS', 'briefTitle': 'Precision Microbiota Interventions for Senoreduction Trial', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Geroprotective Precision Medicine Strategies in PWH That Use Alcohol', 'orgStudyIdInfo': {'id': '8883'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A: Probiotic then Blueberry Extract', 'description': 'Participants receive probiotic for 4 weeks, washout 6 weeks, then blueberry extract for 4 weeks.', 'interventionNames': ['Dietary Supplement: Limosilactobacillus reuteri', 'Dietary Supplement: Blueberry extract']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B: Blueberry Extract then Probiotic', 'description': 'Participants receive blueberry extract for 4 weeks, washout 6 weeks, then probiotic for 4 weeks.', 'interventionNames': ['Dietary Supplement: Limosilactobacillus reuteri', 'Dietary Supplement: Blueberry extract']}], 'interventions': [{'name': 'Limosilactobacillus reuteri', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Sequence A: Probiotic then Blueberry Extract', 'Sequence B: Blueberry Extract then Probiotic']}, {'name': 'Blueberry extract', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Sequence A: Probiotic then Blueberry Extract', 'Sequence B: Blueberry Extract then Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'contacts': [{'name': 'David A Welsh, MD', 'role': 'CONTACT', 'email': 'dwelsh@lsuhsc.edu', 'phone': 'United States', 'phoneExt': '5045684634'}], 'facility': 'LSU Health', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'David A Welsh, MD', 'role': 'CONTACT', 'email': 'dwelsh@lsuhsc.edu', 'phone': 'United States', 'phoneExt': '5045684634'}], 'overallOfficials': [{'name': 'David A Welsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LSU Health New Orleans'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be shared upon reasonable request following publication, subject to data use agreements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center in New Orleans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Welsh', 'investigatorAffiliation': 'Louisiana State University Health Sciences Center in New Orleans'}}}}