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Идёт набор NCT05078957

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

— Наблюдательное HIV Infections

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Stool sampling, Frailty phenotype, Blood plasma collection.
Кому может быть актуально
Состояния в реестре: HIV Infections. Базовые параметры: от 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

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.

Вмешательства

  • Другое Stool sampling
    Stool samples will be collected from participants at baseline and annually during 5 years
  • Другое Frailty phenotype
    According to Fried frailty phenotype based on the assessment of 5 criteria: shrinking (unintentional weight loss), weakness (grip strength), poor endurance (exhaustion), slowness (walking speed) and physical activity. Frail phenotype is defined as the presence of at least 3 criteria of the above mentioned and Pre-frail phenotype as the presence of 1 or 2 criteria.
  • Другое Blood plasma collection
    Blood plasma collection to measure persistent inflammation and immune activation

Первичные конечные точки

  • Variation of the Shannon index between 0 and 5 years in different groups of PLWH [Срок оценки: Five years]
Вторичные конечные точки (3)
  • Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail) [Срок оценки: Three 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 [Срок оценки: Five years]
  • Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different groups of PLWH [Срок оценки: Five years]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital Européen Marseille — Marseille

Идентификаторы

NCT: NCT05078957 · 21-33

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗