NCT05078957

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 132 (estimated)
• Sponsor: Hôpital Européen Marseille · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-12-05
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2021-10-15
• Last updated: 2025-09-25

Locations

1 site across 1 country: France