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MARI: Microbes and Respiratory Illnesses

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059027
Collaborator
(none)
300
Enrollment
50
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is called the Microbes and Respiratory Illnesses (MARI) Study. Children growing up on farms are exposed to many types of microbes that could be beneficial. It is thought that increased exposure to certain types of microbes early in life helps to develop a healthy immune system and reduce the risk for severe common cold illnesses, breathing problems, and allergies.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Respiratory viruses, most notably rhinoviruses (RV), commonly infect school-age children during the month of September and are a well-known exposure for asthma exacerbations. Allergic sensitization is a risk factor for increased viral respiratory illness burden and wheezing. Nasal Airway Epithelial Cell (NAEC) responses to viral exposure show distinct transcriptional programs that differ in individuals with allergies or asthma. There is a growing body of evidence strongly suggesting nasal airway microbial communities enriched in several commensal bacteria are associated with protection from symptomatic RV infections. Metagenomic sequencing from previously collected nasal samples obtained at age 2 years showed distinct microbial communities and function in the Plain Community Cohort compared to farm and non-farm children. How the early life nasal microbial community can impact risk for viral respiratory infection symptoms and NAEC biology remains an important and unresolved question. To address this important question, this proposal includes an observational study to identify patterns of nasal airway gene expression among three cohorts of school-age children that markedly differ in their susceptibility to respiratory illnesses and wheezing: children from Plain/Amish communities, suburban children without asthma, and suburban children with asthma.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Microbes and Respiratory Illnesses, The MARI Study
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Plain Cohort

    Plain Community Children
    Madison Cohort with Asthma

    Madison-area Children with Asthma
    Madison Cohort without Asthma

    Madison-area Children without Asthma

    Outcome Measures

    Primary Outcome Measures

    1. Respiratory Illness Burden Index (RIBI) [30 days]

      The primary outcome for illness severity will be the Respiratory Illness Burden Index (RIBI), which is calculated as the area under the curve (AUC) for symptom scores and days of illness, as previously described. It is calculated by summing the WURSS (cold symptoms assessment) scores for each day of respiratory illness during the observation period.

    Secondary Outcome Measures

    1. Frequency of respiratory illnesses during the monitoring period [30 days]

      Frequency of respiratory illnesses during the monitoring period. Respiratory illnesses are defined as parental perception of respiratory illness symptoms (cold, cough or wheeze) above baseline symptoms.

    2. Virus detection rates in weekly surveillance samples [30 days]

      Virus detection rates in weekly surveillance samples. This will be defined as the detection of a respiratory virus in the weekly nasal mucus specimens.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Participant and/or parent guardian must be able to understand and provide informed consent

    2. Children ages 4-12 years of age

    3. Cohort 1: Family is self-identified as Plain community member

    4. Cohort 2: Madison-area children with parental report of doctor-diagnosed asthma

    5. Cohort 3: Madison-area children with no history of asthma by parental report

    Exclusion Criteria:

    1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol

    2. Chronic sinusitis (frequent sinus infections)

    3. Plans to move out of the area before completing the study

    4. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

    5. Enrolled family member

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: James Gern, MD, UW Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT06059027
    Other Study ID Numbers:
    • 2023-1033
    First Posted:
    Sep 28, 2023
    Last Update Posted:
    Oct 2, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 2, 2023