The Sinonasal Cavity as a Reservoir for Upper Airway Bacterial Development
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03016689|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : September 4, 2020
While the maternal-newborn exchange of airway microbiota is well-documented, no studies have examined within-subject relationships among the mouth, sinuses, nasopharynx and lungs and the relative abundance of bacterial taxa at those sites. Recent evidence suggests the oral cavity may serve as a reservoir for pathogens that translocate to non-oral locations; oral-associated microbes infect most other body sites as evidence by 16S sequencing.
By using a combination of oral and throat swabs, together with nasal suction of mucus samples, the investigators will use metagenomic sequencing to characterize the composition of bacterial communities at each anatomical site. Beginning at birth, a time-series of swabs will be collected from each subject, and monitor changes in the development of microbiota over time. By doing so, our studies will illuminate airway trafficking of both beneficial and pathogenic microbes and may represent an essential pathophysiological step towards shifting the balance between airway health and disease.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||The Sinonasal Cavity as a Reservoir for Upper Airway Bacterial Development|
|Actual Study Start Date :||May 31, 2017|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
- The sinonasal cavity as a reservoir for upper airway bacterial development [ Time Frame: 3 years ]The primary outcome measure will be the development and composition of bacterial communities throughout the respiratory tract during the first year of life. Community composition will be assessed using 16S rRNA sequencing, and differences between body sites will be calculated using standard ecological metrics.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016689
|Contact: Cynthia B Williams, CCRCfirstname.lastname@example.org|
|Contact: Ryan Hunter, PhDemail@example.com|
|Principal Investigator:||Ryan Hunter, PhD||University of Minnesota|