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NCT Number: NCT07672522

Exploratory Study on Infection and Immunosenescence Based on an Elderly Clinical Cohort

This prospective observational cohort study aims to investigate the relationship between immunosenescence and infectious diseases in older adults. Individuals aged 60 years and older, including elderly patients with infections and healthy controls, will be enrolled and followed longitudinally.

Clinical information, laboratory test results, and health assessment data will be collected. Biological specimens, including peripheral blood, urine, stool, sputum, and nasopharyngeal swabs, will be obtained during enrollment and follow-up. Participants will undergo regular assessments of health status, infection events, and aging-related clinical characteristics.

The study will evaluate age-related changes in immune function, immune cell composition, immune receptor repertoires, epigenetic characteristics, metabolic profiles, and respiratory and gut microbiota. By integrating clinical and multi-omics data, the study aims to identify biomarkers associated with immunosenescence, susceptibility to infection, disease severity, and clinical outcomes in older adults.

The results are expected to improve understanding of the mechanisms linking aging, immune dysfunction, and infectious diseases, and to support the development of predictive models and preventive strategies for infection management and healthy aging in elderly populations.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Jingwen Ai, MD

CONTACT

[email protected]

86+13764990804

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for the Healthy Control Group

  • No clinical symptoms suggestive of infection, including fever, cough, dyspnea, fatigue, or myalgia.
  • No abnormal physical signs, including lymphadenopathy, hepatomegaly, splenomegaly, or skin rash.
  • Normal laboratory test results, including complete blood count (CBC), C-reactive protein (CRP), and liver and renal function tests.
  • Healthy adults without underlying chronic diseases, no history of infectious diseases within the previous 6 months, and generally normal cognitive function.
  • Male or female.
  • Able to understand the study procedures and voluntarily provide written informed consent.

Inclusion criteria

for the Infection Group 1.Age: 60 years or older; no gender restrictions. 2. Clinically diagnosed with an infectious disease by the treating physician. 3. The participant provides informed consent and signs the relevant documents.

-------------- Exclusion Criteria for the Healthy Control Group

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

Exclusion criteria

for the Infection Group

  • Final primary diagnosis is a non-infectious disease (e.g., connective tissue disease, tumor, or other conditions).
  • Positive culture results are determined by the clinician to be due to colonization or contamination rather than infection.
  • Refusal to participate in the study.
  • Patients in critical or severe conditions who are unable to cooperate with sample collection.
  • Other conditions deemed unsuitable for inclusion as determined by the researchers.

Treatment and study plan

Primary outcomes

  1. Proportion of peripheral immune cell subset

    Time frame: Baseline to 5 years

    Proportion of peripheral blood immune cell subsets in the infection group versus the healthy control group.

Secondary outcomes

  1. DNA methylation level

    Time frame: Baseline to 5 years

    Chromatin accessibility of peripheral blood mononuclear cells.

  2. Metabolite abundance (metabolomic profiling)

    Time frame: Baseline to 5 years

    Abundance of metabolites in plasma and urine.

  3. Respiratory and gut microbiota diversity measured by microbiome sequencing

    Time frame: Baseline to 5 years

    Diversity of respiratory tract and gut microbiota, measured by microbiome sequencing and reported as the Shannon diversity index.

Study contacts

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

Jingwen Ai, MD

CONTACT

[email protected]

86+13764990804

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 29, 2026
Registry last updated
Jun 29, 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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