VirusMARINCT06059027
Microbes and Respiratory Illnesses
An observational study of Virus and Asthma, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 6 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Participant and/or parent guardian must be able to understand and provide informed consent
- Children ages 4-12 years of age
- Cohort 1: Family is self-identified as Traditional agrarian (TA) Community member
- Cohort 2: Madison-area children with parental report of doctor-diagnosed asthma
- Cohort 3: Madison-area children with no history of asthma by parental report
- Cohort 4: Madison-area children who have an active respiratory illness
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Chronic sinusitis (frequent sinus infections)
- Plans to move out of the area before completing the study
- 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
- Enrolled family member
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Microbes and Respiratory Illnesses, The MARI Study
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.
Read the 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.
- Medical subject headings
- Virus Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start18 Oct 2023
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Gern, MD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059027
- Sponsor's protocol ID
- 2023-1033
- Other IDs
- 2U19AI104317, Protocol Version 4/30/2025, A536770
- Acronym
- MARI
- Status last verified
- Jan 2026
- First submitted
- 22 Sep 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summary level participant data will be shared but not individual level data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbes and Respiratory Illnesses, The MARI Study
- ClinicalTrials.gov ID
- NCT06059027
- Acronym / sponsor ID
- MARI / 2023-1033
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- Participant and/or parent guardian must be able to understand and provide informed consent
- Children ages 4-12 years of age
- Cohort 1: Family is self-identified as Traditional agrarian (TA) Community member
- Cohort 2: Madison-area children with parental report of doctor-diagnosed asthma
- Cohort 3: Madison-area children with no history of asthma by parental report
Key exclusion criteria (5 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Chronic sinusitis (frequent sinus infections)
- Plans to move out of the area before completing the study
- 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
- Enrolled family member
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Illness Burden Index (RIBI)
Time frame: 30 days
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.
2 secondary outcomes
Frequency of respiratory illnesses during the monitoring period
Time frame: 30 days
Virus detection rates in weekly surveillance samples
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. Summary level participant data will be shared but not individual level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Gern, MD principal investigator
UW Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Virus and Asthma, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Illness Burden Index (RIBI) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.