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Microbes and Respiratory Illnesses

Microbes and Respiratory Illnesses, The MARI Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06059027
Acronym
MARI
Enrollment
290
Registered
2023-09-28
Start date
2023-10-18
Completion date
2025-11-06
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Virus

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.

Interventions

None listed

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Illness Burden Index (RIBI)30 daysThe 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

MeasureTime frameDescription
Frequency of respiratory illnesses during the monitoring period30 daysFrequency 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.
Virus detection rates in weekly surveillance samples30 daysVirus detection rates in weekly surveillance samples. This will be defined as the detection of a respiratory virus in the weekly nasal mucus specimens.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026