NCT05078957Recruiting
Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 132 (estimated)
- First submitted
- 17 Sept 2021
- Start date
- 5 Dec 2023
- Primary completion date
- Mar 2030
- Lead sponsor
- Hôpital Européen Marseille
- Diseases
- HIV
- NCT number
- NCT05078957
What you commit to
- Study type: Observational
- Planned participants: 132
- From 5 Dec 2023 to the primary completion date, Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling.
Other illness
- Subject in the primary infection phase of less than 1 year
Other
- Subject not followed regularly in the participating center,
- Subject only coming for full hospitalization
Who the study is looking for
- 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.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.