Microbes and Respiratory Illnesses

Asthma Clinical Trial

— MARI  

Official title:

Microbes and Respiratory Illnesses, The MARI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059027
• Other study ID #: 2023-1033
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: Gina Crisafi, BS
• Phone: 608-262-5240
• Email: gmc[@]medicine.wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Virus

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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