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Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV

NCT05078957 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

OTHER

Stool sampling

Stool samples will be collected from participants at baseline and annually during 5 years

OTHER

Frailty phenotype

According to Fried frailty phenotype based on the assessment of 5 criteria: shrinking (unintentional weight loss), weakness (grip strength), poor endurance (exhaustion), slowness (walking speed) and physical activity. Frail phenotype is defined as the presence of at least 3 criteria of the above mentioned and Pre-frail phenotype as the presence of 1 or 2 criteria.

OTHER

Blood plasma collection

Blood plasma collection to measure persistent inflammation and immune activation

Sponsors & Collaborators

  • Hôpital Européen Marseille

    lead OTHER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2030-03-31
Completion
2030-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078957 on ClinicalTrials.gov