Investigating the role of the sinonasal cavity in bacterial development in cystic fibrosis patients
The Sinonasal Cavity as a Reservoir for Upper Airway Bacterial Development
This study looks at how bacteria in the mouth, sinuses, and lungs of young children with cystic fibrosis change over time to see how they might affect their breathing health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 7 Days to 3 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT03016689 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationships among the mouth, sinuses, nasopharynx, and lungs in young children diagnosed with cystic fibrosis. By collecting oral and throat swabs, along with nasal mucus samples, the researchers will utilize metagenomic sequencing to analyze the bacterial communities present at these anatomical sites. The study will track changes in microbiota development from birth, providing insights into how beneficial and pathogenic microbes may affect respiratory health over time.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and young children aged 0-3 years who have been diagnosed with cystic fibrosis.
Not a fit: Patients with additional complications such as vasculitis or rheumatologic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of the microbiome's role in respiratory health and inform strategies for managing cystic fibrosis.
How similar studies have performed: While studies on gut microbiota have shown success, this specific investigation into respiratory tract microbiota in cystic fibrosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of CF by sweat chloride test \>60 mEq/L or by presence of two known CF genetic mutations * Age 0-3 years * Willingness to comply with study procedures * Willingness of parent/guardian to provide written consent. Exclusion Criteria: • Presence of vasculitis or rheumatologic disorder
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ryan Hunter, PhD — University of Minnesota
- Study coordinator: Cynthia B Williams, CCRC
- Email: will1925@umn.edu
- Phone: 612/6257464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.