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Research Project on the Interaction Between Immune Function and Infectious Diseases in Older Adults and the Development of Prevention and Control Strategies

2026年6月8日 更新者:Wen-hong Zhang、Huashan Hospital

As population aging accelerates, infectious diseases have become a major factor affecting the health, quality of life, and survival outcomes of older adults. Immunosenescence, chronic low-grade inflammation (inflammaging), and dysbiosis of the respiratory and gut microbiota are considered important mechanisms underlying increased susceptibility to infection and a higher risk of severe disease in older adults. However, the interactions among these factors and their impact on infection-related outcomes remain incompletely understood.

Building upon a previously established pilot cohort of older adults, this study aims to further identify and validate key biological characteristics and risk factors associated with infectious diseases through large-scale population follow-up. A large prospective cohort of older adults will be established, while retrospective healthcare data collected since 2019 will also be integrated. Demographic information, comorbidities, medication history, infection-related clinical data, and biological specimens, including blood, urine, fecal, and respiratory samples, will be collected for long-term longitudinal follow-up. By integrating immunological assessments, immune repertoire analyses, microbiome profiling, and other multi-omics technologies, this study will systematically evaluate the effects of immunosenescence, respiratory and gut microbiome alterations, and environmental and climatic factors on the occurrence, severity, and prognosis of infectious diseases in older adults. The study aims to identify key biomarkers and microbial signatures associated with infection risk and to develop risk prediction and early warning models for infectious diseases in older adults, thereby providing scientific evidence for precision prevention, optimized clinical management, and public health decision-making in aging populations.

研究概览

地位

尚未招聘

研究类型

观察性的

注册 (估计的)

23000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Adults aged 60 years and older

描述

Inclusion Criteria:

- General Cohort Inclusion Criteria

  1. Adults aged 60 years or older who are in generally good health, defined as having no severe organ dysfunction that significantly affects daily living activities (e.g., decompensated heart, liver, or kidney failure), adequate nutritional status (without significant wasting or malnutrition), and the ability to communicate and comply with study procedures.
  2. Male or female.
  3. Able to understand the study and voluntarily provide written informed consent.

Infection Cohort Inclusion Criteria

  1. Adults aged 60 years or older, regardless of sex.
  2. Patients with an infectious disease diagnosed by a qualified clinician.

Exclusion Criteria:

  • General Cohort Exclusion Criteria

    1. Refusal to participate in this study.
    2. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.

Infection Cohort Exclusion Criteria

  1. Final primary diagnosis is a non-infectious disease (e.g., connective tissue disease, malignancy, or other non-infectious conditions).
  2. Positive culture results determined by the treating clinician to represent colonization or contamination rather than true infection.
  3. Refusal to participate in this study.
  4. Critically ill patients or those unable to cooperate with specimen collection procedures.
  5. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Older Adults Without Infection
Community-dwelling adults aged 60 years and older who do not develop any clinically diagnosed infectious disease during the follow-up period.
Older Adults With Infection
Community-dwelling adults aged 60 years and older who develop clinically diagnosed infectious diseases during follow-up.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Occurrence of infectious disease outcomes in older adults
大体时间:Baseline to 3 years
Occurrence of infectious disease outcomes in older adults, including all-cause mortality, infection-related mortality, first infectious disease event, and progression to severe infection.
Baseline to 3 years

次要结果测量

结果测量
措施说明
大体时间
High-Frequency Infection Status (≥6 Infections per Year)
大体时间:Baseline to 3 Years
Defined as an average of six or more infectious episodes per year during follow-up.
Baseline to 3 Years
Pathogen-Specific Infection Events
大体时间:Baseline to 3 Years
Infectious disease events caused by specific pathogens, used to evaluate pathogen distribution and temporal trends.
Baseline to 3 Years
Changes in Immune Function Biomarkers
大体时间:Baseline to 3 Years
Assessment of longitudinal changes in immune cell subsets and immune function status.
Baseline to 3 Years

其他结果措施

结果测量
措施说明
大体时间
Changes in Metabolomic and Microbiome Profiles
大体时间:Baseline to 3 Years
Assessment of longitudinal changes in metabolomic profiles and gut and respiratory microbiome characteristics associated with infection risk and disease severity.
Baseline to 3 Years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月9日

初级完成 (估计的)

2029年12月30日

研究完成 (估计的)

2029年12月30日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 20260306-001

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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