Skip to main content
OpenTrials
Completed

NCT Number: NCT06059027

Microbes and Respiratory Illnesses

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

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 Traditional agrarian (TA) 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 TA/Amish communities, suburban children without asthma, and suburban children with asthma.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant and/or parent guardian must be able to understand and provide informed consent
  • Children ages 4-12 years of age
  • Cohort 1: Family is self-identified as Traditional agrarian (TA) Community member
  • Cohort 2: Madison-area children with parental report of doctor-diagnosed asthma
  • Cohort 3: Madison-area children with no history of asthma by parental report
  • Cohort 4: Madison-area children who have an active respiratory illness

Exclusion criteria

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Chronic sinusitis (frequent sinus infections)
  • Plans to move out of the area before completing the study
  • 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
  • Enrolled family member

Treatment and study plan

Primary outcomes

  1. Respiratory Illness Burden Index (RIBI)

    Time frame: 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 outcomes

  1. Frequency of respiratory illnesses during the monitoring period

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Microbes and Respiratory Illnesses, The MARI Study

Acronym: MARI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2023
Registry last updated
Jan 16, 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.

Published trials that share one or more normalized conditions with this study.