Exploring gut microbiota and frailty in older people living with HIV
Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Hôpital Européen Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT05078957 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older, living with HIV, who have been virologically suppressed for at least five years.
Not a fit: Patients who are currently undergoing treatment that disrupts gut microbiota, such as antibiotics or probiotics, may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Marseille
- Hôpital Européen Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Myriam BENNANI
- Email: m.bennani@hopital-europeen.fr
- Phone: 0413428351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.