{"type":"trials","record":{"id":33762,"source_id":"clinicaltrials-gov","external_id":"NCT05078957","title":"Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV","brief_summary":"Analysis of gut microbiota becomes more and more accessible in recent years. Experimental data in both animal and human studies have demonstrated that imbalance of the gut microbiota which is called symbiosis may participate in an accelerated procedure of ageing as well as the expression of frailty phenotype. People living with HIV (PLHIV) present markers of phenotypic frailty on average 10 years before uninfected people. In this population structural and functional modifications of GALT (Gut Associated Lymphoid Tissue) are observed early after HIV infection and persist despite virological suppression on ART (AntiRetroviral Treatment). These GALT modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis. The objective of study is to explore gut microbiota of PLWH over 5 years, as well as to study associations of its longitudinal evolution with frailty markers and burden of comorbidities.","overall_status":"Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Hôpital Européen Marseille","enrollment":132,"countries":["France"],"start_date":"2023-12-05","completion_date":"2030-03-01","last_update_date":"2025-09-25","source_url":"https://clinicaltrials.gov/study/NCT05078957","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:11.953004+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"FRAMIVIH","age_range":"55 Years","comparator":null,"organization":"Hôpital Européen Marseille","interventions":["Stool sampling","Frailty phenotype","Blood plasma collection"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Variation of the Shannon index between 0 and 5 years in different groups of PLWH — Five years","Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail) — Three…","Assaying inflammation markers(CRP, IL-6, sCD14, sCD163, TNFa, IP10, I-FABP, LBP, D-dimers, K/T ratio) annually and for…","Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different…"],"design_description":null,"source_has_results":false},"controlled_terms":["HIV Infections","Stool sampling","Frailty phenotype","Blood plasma collection"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct05078957","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-12-05 to 2030-03-01","comparator":null,"confidence":"structured-source","population":"ALL · 55 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.484Z","intervention":["Stool sampling","Frailty phenotype","Blood plasma collection"],"participants":132,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Variation of the Shannon index between 0 and 5 years in different groups of PLWH — Five years","Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail) — Three…","Assaying inflammation markers(CRP, IL-6, sCD14, sCD163, TNFa, IP10, I-FABP, LBP, D-dimers, K/T ratio) annually and for…","Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33762","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}