Clinical trial Recruiting at 1 site Observational Ages 55 and up

Exploring gut microbiota and frailty in older people living with HIV

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

Run by Hôpital Européen Marseille · NCT05078957 · Data updated 2026-11-12

This study looks at how changes in gut bacteria might affect older adults with HIV in terms of frailty and other health issues over five years.

More HIV Infections trials

Quick facts

Study typeObservational
Ages55 Years and up
SexAll
Enrollment132 (estimated)
SponsorHôpital Européen Marseille
Academic / other
Locations1 site (Marseille)
StatusRecruiting
StartedDecember 5, 2023
Main results expectedMarch 2030
Study endsMarch 2030
Registry record updatedSeptember 25, 2025
Trial IDNCT05078957 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 55 and older, living with HIV, who have been virologically suppressed for at least five years.

Probably not a fit

Patients who are currently undergoing treatment that disrupts gut microbiota, such as antibiotics or probiotics, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes the gut microbiota of individuals living with HIV who have maintained virological suppression for at least five years. It aims to investigate the relationship between gut microbiota changes and the development of frailty markers and comorbidities over a five-year period. Participants will undergo stool sampling and blood plasma collection to assess their microbiota and health status. The study focuses on individuals aged 55 and older, who have stable HIV infections and meet specific health criteria.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of frailty in older adults living with HIV.

How similar studies have gone: While the specific approach of this study may be novel, previous studies have indicated a connection between gut microbiota and health outcomes in various populations, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Hôpital Européen Marseille
    Marseille, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.