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Cystic FibrosisNCT03016689

The Sinonasal Cavity as a Reservoir for Upper Airway Bacterial Development

An observational study of Cystic Fibrosis, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 days to 3 years
Conditions the study is for
Cystic Fibrosis
How many people
7 participants
Where
1 siteUnited States
Study dates
31 May 2017to 12 Sep 2019
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 7 days to 3 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Infants with Cystic Fibrosis who receive their care at the University of Minnesota Discovery Care Clinic.

Who may be able to join

  • 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.

Who cannot join

  • Presence of vasculitis or rheumatologic disorder

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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.

Read the detailed description

The study of microbial community dynamics is critically important to human health, including how to maintain or restore a healthy microbiome. Metagenomic studies have revolutionized microbiology by addressing these issues in a culture-independent manner, and have defined essential roles of the microbiota in host development. The initial development of gut microbiota begins in utero and is strongly influenced by exposures at birth (e.g. vaginal vs caesarean birth). The initial seeding by the mother's microflora and its ensuing bacterial succession is thought to have critical long-term impacts on human health. Recent longitudinal studies have documented a gradual increased in bacterial diversity, non-random community assembly, the effects of breast milk and introduction of table foods, and large taxonomic shifts as a result of antibiotics and environmental stresses that occur during infancy. Since perturbations of these early events have been linked to diabetes, cancer, mental health and a range of other maladies, efforts are underway to learn how manipulation of the infant microbiome to a "healthy" state translates into long-term clinical outcomes.

By contrast, little attention has been paid to factors that govern the early-life development of respiratory tract microbiota, including the oral cavity. At birth, the oral and nasopharyngeal flora resemble those of the maternal vaginal tract or skin (depending on mode of delivery). Preliminary datasets suggest that during the first year of life, the airway microbiome evolves into a rich, adult-like microbial ecosystem. The keystone colonizers of the airways are thought to condition the subsequent colonization by over 600 species, some of which serve to establish robust bacterial communities characteristic of human health. Other secondary colonizers are frequently implicated in oral and respiratory infections, including chronic sinusitis, pneumonia, and periodontal diseases. As an example, infant colonization by Streptococcus pneumoniae is an important risk factor for childhood middle ear disease. Early microbial communities, therefore, represent major factors that govern the colonization of the airways by both pathogenic and protective microbes during infant microbiome development. Understanding the acquisition of infant airway microbial communities and the factors that alter their composition is critical to the promotion of human health and the prevention of airway diseases that represent an annual multi-billion dollar burden on the US healthcare system.

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 trans-locate to non-oral locations; oral-associated microbes infect most other body sites as evidence by 16S sequencing. However, two caveats make this bacterial metastasis controversial. First, that oral bacteria are not located solely in the mouth but are also found elsewhere in the airways makes their origin difficult to establish. Thus, the directionality of microbial exchange between airway niche spaces is not known. Secondly, most 16S ribosomal RNA (rRNA) surveys only reveal bacterial composition at the genus or phylum level, providing little information about strain lineages, and whether individual strains can migrate between sites. These data are critical to promote development of protective microbiota while restricting growth of recalcitrant pathogens.

A more complete understanding of this trafficking begins with in-depth, strain-level surveys of the bacterial communities present in each airway niche shortly after birth, and their development over time. As a step in this direction, this Academic Health Center-sponsored study will use metagenomic sequencing to assess the exchange of specific bacterial strains throughout the upper airways. Our mouse studies (explained elsewhere) will be complemented by a study of cystic fibrosis (CF) infants, who represent a unique population that facilitates the capture of oral, sinonasal, and lung microbiota over the first two years of life. By using a combination of oral and throat swabs, together with nasal suction of mucus samples, a metagenomic sequencing approach will be used to characterize the composition of bacterial communities at each anatomical site. Beginning at birth, the investigators will collect a time-series of swabs 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.

EXPERIMENTAL PLAN The development of airway bacterial communities will be monitored in a small CF patient cohort. Since CF infants are monitored from birth and are routinely sampled for airway microbiota during routine outpatient visits as part of their standard-of-care, they represent a unique population to monitor bacterial trafficking between the oral, nasal and lung cavities. All newborns at the University of Minnesota (UMN) are genetically screened. Those testing positive for CF will be confirmed using a pilocarpine sweat test. Positive subjects (with 2 Cystic Fibrosis Transmembrane Conductance Regulator [CFTR] mutations) will then be sampled during the participants' visits to the CF treatment center; on average, infants will be seen every month for the first 6 months, every other month until 1 year of age, followed by quarterly visits to the UMN CF Center (in accordance with Cystic Fibrosis Foundation guidelines). As part of standard of care, nasal samples are collected by suction at each visit. Nylon swabs will also be used to sample each infant's buccal mucosa. Oropharyngeal swabs will also be obtained, which are considered to be an accurate proxy of lower airway (lung) microbiomes. Based on the number of CF newborns expected over the study period, the investigators plan to recruit up to 10 subjects. From each infant, up to 10 temporal swabs will be collected from each airway site (10 infants x 10 swabs x 3 sites = 300 samples). Swabs will be stored in saline, frozen at -80C and processed in parallel.

DNA will be extracted from each swab sample, and sequencing performed at the University of Minnesota Genomics Center.

Conditions
Cystic Fibrosis
Medical subject headings
Cystic Fibrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The sinonasal cavity as a reservoir for upper airway bacterial development

    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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2017 (estimated)
  2. Study start31 May 2017
  3. Primary completion12 Sep 2019
  4. Study completion12 Sep 2019

Resources

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
Case only
Time perspective
Prospective
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03016689
Sponsor's protocol ID
MICRO-2016-25363
Status last verified
Feb 2026
First submitted
9 Jan 2017
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cystic Fibrosis, run by University of Minnesota 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 4 inclusion and 1 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 20 Feb 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?

The sinonasal cavity as a reservoir for upper airway bacterial development (time frame: 3 years). 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 20 Feb 2026.

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