Microbes and Respiratory Illnesses

NCT ID: NCT06059027

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 290 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2025-11-06

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.

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 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.

Conditions

Virus; Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TA Cohort

Traditional agrarian (TA) Community Children

No interventions assigned to this group

Madison Cohort with Asthma

Madison-area Children with Asthma

No interventions assigned to this group

Madison Cohort without Asthma

Madison-area Children without Asthma

No interventions assigned to this group

Madison Cohort with Active Respiratory Illness

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

No interventions assigned to this group

Eligibility Criteria

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 Traditional agrarian (TA) 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

6. Cohort 4: Madison-area children who have an active respiratory illness

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Gern, MD

Role: PRINCIPAL_INVESTIGATOR

UW Madison

Locations

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2U19AI104317

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Protocol Version 4/30/2025

Identifier Type: OTHER

Identifier Source: secondary_id

A536770

Identifier Type: OTHER

Identifier Source: secondary_id

2023-1033

Identifier Type: -

Identifier Source: org_study_id