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NCT06059027 | RECRUITING | Virus

Microbes and Respiratory Illnesses
Sponsor:

University of Wisconsin, Madison

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.

Condition or disease

Virus

Asthma

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
Estimated Enrollment : 350 participants
Official Title : Microbes and Respiratory Illnesses, The MARI Study
Actual Study Start Date : 2023-10-18
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Years to 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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 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
Microbes and Respiratory Illnesses

Location Details

NCT06059027

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Wisconsin

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States, 53792