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

Recruiting

• Conditions: HIV Infections
• Interventions: Other: Stool sampling; Other: Frailty phenotype; Other: Blood plasma collection

• Registration Number: NCT05078957
• Lead Sponsor: Hôpital Européen Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-15
• Status Verified: 2023-12
• Study Start: 2023-12-05
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2025-04
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Frail PLWH	Stool sampling	-
Frail PLWH	Frailty phenotype	-
No frail PLWH	Stool sampling	-
No frail PLWH	Frailty phenotype	-
No frail PLWH	Blood plasma collection	-
Frail PLWH	Blood plasma collection	-
Pre frail PLWH	Frailty phenotype	-
Pre frail PLWH	Stool sampling	-
Pre frail PLWH	Blood plasma collection	-

Primary Outcome Measures

Name	Time	Method
Variation of the Shannon index between 0 and 5 years in different groups of PLWH	Five years

Secondary Outcome Measures

Name	Time	Method
Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail)	Three years
Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different groups of PLWH	Five years
Assaying inflammation markers(CRP, IL-6, sCD14, sCD163, TNFa, IP10, I-FABP, LBP, D-dimers, K/T ratio) annually and for 5 years in different groups of PLWH	Five years

Trial Locations

Locations (1)

Hôpital Européen Marseille; 🇫🇷 Marseille, France