Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV
Recruiting now
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT05078957
- Run by
- Hôpital Européen Marseille
- People needed
- 132
- Starts
- 2023-12-05
- Expected to finish
- 2030-03-01
- Last updated by the study team
- 2025-09-25
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Hôpital Européen Marseille — Marseille, France (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.