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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07672522
Enrollment
484
Registered
2026-06-29
Start date
2024-11-29
Completion date
2029-10-30
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosenescence

Brief summary

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.

Interventions

None listed

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for the Healthy Control Group 1. No clinical symptoms suggestive of infection, including fever, cough, dyspnea, fatigue, or myalgia. 2. No abnormal physical signs, including lymphadenopathy, hepatomegaly, splenomegaly, or skin rash. 3. Normal laboratory test results, including complete blood count (CBC), C-reactive protein (CRP), and liver and renal function tests. 4. Healthy adults without underlying chronic diseases, no history of infectious diseases within the previous 6 months, and generally normal cognitive function. 5. Male or female. 6. 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 1. Refusal to participate in the study; 2. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of peripheral immune cell subsetBaseline to 5 yearsProportion of peripheral blood immune cell subsets in the infection group versus the healthy control group.

Secondary

MeasureTime frameDescription
DNA methylation levelBaseline to 5 yearsChromatin accessibility of peripheral blood mononuclear cells.
Metabolite abundance (metabolomic profiling)Baseline to 5 yearsAbundance of metabolites in plasma and urine.
Respiratory and gut microbiota diversity measured by microbiome sequencingBaseline to 5 yearsDiversity of respiratory tract and gut microbiota, measured by microbiome sequencing and reported as the Shannon diversity index.

Countries

China

Contacts

CONTACTJingwen Ai, MD
jingwenai1990@126.com86+13764990804

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026