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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
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

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
Cystic Fibrosis

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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
Oral and oropharyngeal swabs will be collected


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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants with Cystic Fibrosis who receive their care at the University of Minnesota Discovery Care Clinic.
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


Information from the National Library of Medicine

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


Contacts
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Contact: Cynthia B Williams, CCRC 612/6257464 will1925@umn.edu
Contact: Ryan Hunter, PhD 612-625-1402 rchunter@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ryan C Hunter, PhD    612-625-1402    rchunter@umn.edu   
Contact: Terri A Laguna, MD    612/624-6967    laguun005@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Ryan Hunter, PhD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03016689    
Other Study ID Numbers: MICRO-2016-25363
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases