Microbes and Respiratory Illnesses

NCT06059027 | Completed

• 4 other identifiers: 2023-10332U19AI104317Protocol Version 4/30/2025A536770
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Virus; Asthma

Outcome Measures

Primary Outcomes (1)

• Respiratory Illness Burden Index (RIBI)

  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.

  30 days

Secondary Outcomes (2)

• Frequency of respiratory illnesses during the monitoring period

  30 days

• Virus detection rates in weekly surveillance samples

  30 days

Study Arms (4)

TA Cohort

Traditional agrarian (TA) Community Children

Madison Cohort with Asthma

Madison-area Children with Asthma

Madison Cohort without Asthma

Madison-area Children without Asthma

Madison Cohort with Active Respiratory Illness

Madison-area children with active respiratory illness, with or without asthma

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This study will be recruited from the LaFarge Medical Clinic and the University of Wisconsin Hospitals and Clinics (Madison area) and the demographics of the participants enrolled will reflect those of the area. It is anticipated that approximately 50% of the study participants will be female. Participation of minority ethnic and racial groups will be encouraged. It is expected that the study population will reflect the demographics of the TA (all White) and Madison (approximately 25% minority) communities. Despite no representation of ethnic minorities, the TA population is a uniquely valuable cohort.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Types of samples collected will include: * Blood * Nasal Sampling: * Nasal Swab: Nasal cells and mucus will be collected by putting a tiny swab (the size of a Q-tip) in the nose moved in and out for 4 seconds. The swab is then removed from the nose. During the baseline visit, the study team will teach the child how to collect this swab at home for the weekly collection. The family will be given the materials to take home to be able to collect the nasal swab at home and mail it back to the study site. * Nasal Filter Paper: Nasal secretions will be collected by inserting an absorbent strip into the child's nose for 1-2 minutes. * Saliva (spit) * Genetic Testing: Some of the tests performed on the child's saliva and nasal samples will be genetic testing

MeSH Terms

Conditions

Virus Diseases; Asthma

Condition Hierarchy (Ancestors)

Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• James Gern, MD

  UW Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: October 18, 2023
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)