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

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.

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Key information

Conditions

Infectious Diseases Aging Communicable Diseases Disease Attributes Immunosenescence Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General Cohort Inclusion Criteria

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.
Male or female.
Able to understand the study and voluntarily provide written informed consent.

Infection Cohort Inclusion Criteria

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

Exclusion criteria

General Cohort Exclusion Criteria

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

Infection Cohort Exclusion Criteria

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

Treatment and study plan

Primary outcomes

Occurrence of infectious disease outcomes in older adults

Time frame: 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.

Secondary outcomes

High-Frequency Infection Status (≥6 Infections per Year)

Time frame: Baseline to 3 Years

Defined as an average of six or more infectious episodes per year during follow-up.
Pathogen-Specific Infection Events

Time frame: Baseline to 3 Years

Infectious disease events caused by specific pathogens, used to evaluate pathogen distribution and temporal trends.
Changes in Immune Function Biomarkers

Time frame: Baseline to 3 Years

Assessment of longitudinal changes in immune cell subsets and immune function status.

Other outcomes

Changes in Metabolomic and Microbiome Profiles

Time frame: Baseline to 3 Years

Assessment of longitudinal changes in metabolomic profiles and gut and respiratory microbiome characteristics associated with infection risk and disease severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingwen Ai

CONTACT

[email protected]

17317958269

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jun 12, 2026
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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