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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

8 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Studietyp

Observationell

Inskrivning (Beräknad)

23000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Adults aged 60 years and older

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Occurrence of infectious disease outcomes in older adults
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
High-Frequency Infection Status (≥6 Infections per Year)
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to 3 Years
Assessment of longitudinal changes in immune cell subsets and immune function status.
Baseline to 3 Years

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in Metabolomic and Microbiome Profiles
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

9 juni 2026

Primärt slutförande (Beräknad)

30 december 2029

Avslutad studie (Beräknad)

30 december 2029

Studieregistreringsdatum

Först inskickad

8 juni 2026

Först inskickad som uppfyllde QC-kriterierna

8 juni 2026

Första postat (Faktisk)

12 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 20260306-001

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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