Clinical trial NCT06059027: Microbes and Respiratory Illnesses
Official title: Microbes and Respiratory Illnesses, The MARI Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Virus
Asthma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-09-28
Enrollment: 350
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Respiratory Illness Burden Index (RIBI)
timeFrame: 30 days
Secondary outcomes:
measure: Frequency of respiratory illnesses during the monitoring period
timeFrame: 30 days
measure: Virus detection rates in weekly surveillance samples
timeFrame: 30 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: UW Madison
name: James Gern, MD
role: PRINCIPAL_INVESTIGATOR
References: