Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Variation of the Shannon index between 0 and 5 years in different groups of PLWH
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Variation of the Shannon index between 0 and 5 years in different groups of PLWH
时间窗: Five years
次要结局
- 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)