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Clinical Trials in France / NCT05078957
Recruiting Observational

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

NCT05078957 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-12-05
Last updated
2025-09-25

Condition(s) studied

HIV Infections

Investigational drug(s) / intervention(s)

Stool samplingFrailty phenotypeBlood plasma collection

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

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.

Blood plasma collection: Blood plasma collection to measure persistent inflammation and immune activation

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Individuals infected with HIV in the stable phase of their disease (absence of disease outbreak and absence of therapeutic modification within 3 months before inclusion), * Subject with ongoing HIV follow-up on an outpatient basis (outpatient or day hospital consultation) in the participating center, and having virological suppression at the threshold of 50 copies / mL for at least 5 years (tolerance of blips \< 200 copies / mL during this period) * Aged ≥ 55 at baseline * CD4 + T cell nadir\> 200 / mm3 * Giving free and informed written consent * Being affiliated with or benefiting from a social security scheme. Exclusion Criteria: * Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling. * Subject not followed regularly in the participating center, * Subject only coming for full hospitalization * Subject in the primary infection phase of less than 1 year

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Européen Marseille Marseille France Recruiting

More Hôpital Européen Marseille trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05078957 on ClinicalTrials.gov ↗ ← All trials in France