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| ID | Type | Description | Link |
|---|---|---|---|
| 2U19AI104317 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 4/30/2025 | Other Identifier | UW Madison | |
| A536770 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| James Gern, MD | UW Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
Summary level participant data will be shared but not individual level data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 16, 2025 | Jan 15, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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Types of samples collected will include:
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 |
| D008171 |
| Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |