Microbes and Respiratory Illnesses (MARI)

Microbes and Respiratory Illnesses, The MARI Study

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Virus

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 Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Gina Crisafi, BS; Phone Number: 608-262-5240; Email: gmc@medicine.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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 Plain (all White) and Madison (approximately 25% minority) communities. Despite no representation of ethnic minorities, the Plain population is a uniquely valuable cohort.

Description

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
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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Plain Cohort; Plain 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of respiratory illnesses during the monitoring period	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.	30 days
Virus detection rates in weekly surveillance samples	Virus detection rates in weekly surveillance samples. This will be defined as the detection of a respiratory virus in the weekly nasal mucus specimens.	30 days

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: James Gern, MD, UW Madison

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-1033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary level participant data will be shared but not individual level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No