Exploratory Study on Infection and Immunosenescence Based on an Elderly Clinical Cohort
ConditionImmunosenescence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorHuashan Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Refusal to participate in the study;
Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
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.
Trial population
Adults aged 60 years and older
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
484 Participants
are grouped into 2 trial groupsGroup A: Infected Older Adults
Group B: Healthy Older Controls
Trial outcomes
Primary outcomes
1
Proportion of peripheral immune cell subset
Proportion of peripheral blood immune cell subsets in the infection group versus the healthy control group.
Time frame
Baseline to 5 yearsSecondary outcomes
1
DNA methylation level
Chromatin accessibility of peripheral blood mononuclear cells.
Time frame
Baseline to 5 years2
Metabolite abundance (metabolomic profiling)
Abundance of metabolites in plasma and urine.
Time frame
Baseline to 5 years3
Respiratory and gut microbiota diversity measured by microbiome sequencing
Diversity of respiratory tract and gut microbiota, measured by microbiome sequencing and reported as the Shannon diversity index.
Time frame
Baseline to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov