Cystic FibrosisNCT02128711
Mapping Chemical and Microbiological Heterogeneity Throughout Explanted Cystic Fibrosis Lung Specimens
An observational study of Cystic Fibrosis, run by University of Minnesota at 1 site in United States.
Trial summary
There is plenty of evidence to suggest that the lung is not uniform. The internal surface area is 30 times that of skin, and the different bronchioles/bronchi/alveoli differ greatly in blood perfusion, temperature, oxygen tension, and pH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2014to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will include those undergoing single or double lung transplantation as part of their normally scheduled therapy for cystic fibrosis disease.
Who may be able to join
- diagnosis of cystic fibrosis
- eligible for lung transplantation
- exhausted other available therapies without success
- informed consent
Who cannot join
- there are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
About this study
There is plenty of evidence to suggest that the lung is not uniform. The internal surface area is 30 times that of skin, and the different bronchioles/bronchi/alveoli differ greatly in blood perfusion, temperature, oxygen tension, and pH. Also, particularly in the context of respiratory disease, notable differences are present in the structure of epithelial cells, cilia, production of mucus, and inflammatory/immune responses. All of these factors are known to impact the physiology of bacteria, yet, there is very little understanding of how they impact a) the presence/absence of particular bacterial species throughout the respiratory tract, or b) the metabolic processes used by these bacteria within the human host environment. A greater understanding of the relationships between environmental (chemical) gradients in the lungs of diseased patients (particularly those with cystic fibrosis) and the microbial communities that are present may lead to novel hypotheses about manipulation of the respiratory environment for therapeutic benefit. To investigate this further, the investigators propose to use explanted lung specimens from cystic fibrosis patients to test the following hypothesis:
Hypothesis: In patients with cystic fibrosis, bacterial community composition, metabolism and environmental chemistry will vary depending on their spatial location within the airways.
Read the detailed description
To study this in greater detail, the investigators propose to study explanted tissue of CF patients that are scheduled to undergo single or double lung transplant surgery as a late-stage disease therapeutic strategy. This population will be limited to the Adult CF clinic, as pediatric subjects are rarely candidates for lung transplantation. The Adult CF Clinic performs upwards of 20 surgeries per year, and tissue that is explanted is typically discarded. Using this tissue, the investigators propose the following objectives:
- Use 16S culture-independent sequencing to characterize the spatial distribution of bacterial pathogens throughout the lungs of cystic fibrosis patients. Lungs will be dissected into 5 separate lobes, and mucus material will be collected, homogenized, and processed for bacterial species identification.
- Perform detailed analysis of specific gene expression throughout the respiratory tract that will serve as a proxy of environmental conditions found there. Using the same approach in Aim 1, bacterial mRNA will be extracted using established procedures. A subset of environmentally-specific genes will be detected to provide a readout of bacterial metabolism in use within the CF lung environment.
- Use in situ hybridization imaging to visualize the spatial distribution of specific bacteria and their gene expression profiles (informed by data generated in objectives 1 and 2). The bacteria and gene candidates identified/studied in Aims 1 and Aims 2 will then be subject to analysis using in situ hybridization imaging. Tissue will be processed using microtomy and fluorescent probes will be applied to image the spatial distribution of specific bacterial species and their metabolisms throughout the respiratory tract.
Information collected in these three objectives will then be paired with patient data (age, genotype, prior medical treatments, clinical microbiology data) to generate better working models of late-stage disease in CF patients.
- Conditions
- Cystic Fibrosis
- Keywords
- lung, cystic fibrosis, bacteria, positive diagnosis of CF,
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of bacterial communities throughout an explanted lung
16S culture-independent sequencing will be used to characterize the spatial distribution of bacterial pathogens throughout the lungs of cystic fibrosis patients. Explanted lung specimens will be dissected into 5 separate lobes, and mucus material will be collected, homogenized, and processed for bacterial species identification.
Measured: Entire study (3 years)
Secondary outcomes (1)
Levels of bacterial gene expression
Gene expression analysis will be used to study bacterial physiology within explanted lungs and will serve as a proxy of environmental conditions found there. Using the same approach in as outcome 1, bacterial mRNA will be extracted using established procedures. A subset of environmentally specific genes will be detected to provide a readout of bacterial metabolism in use within the CF lung environment.
Measured: Entire study (3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study start1 Jul 2014
- Primary completion22 Nov 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ryan C Hunter, PhD, Principal investigator, University of Minnesota Medical School (Microbiology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128711
- Sponsor's protocol ID
- PACCS-2018-27376
- Other IDs
- 4R00HL114862-02
- Status last verified
- Oct 2025
- First submitted
- 25 Apr 2014
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hunter RC, Asfour F, Dingemans J, Osuna BL, Samad T, Malfroot A, Cornelis P, Newman DK. Ferrous iron is a significant component of bioavailable iron in cystic fibrosis airways. mBio. 2013 Aug 20;4(4):e00557-13. doi: 10.1128/mBio.00557-13.
PubMed 23963183Hunter RC, Klepac-Ceraj V, Lorenzi MM, Grotzinger H, Martin TR, Newman DK. Phenazine content in the cystic fibrosis respiratory tract negatively correlates with lung function and microbial complexity. Am J Respir Cell Mol Biol. 2012 Dec;47(6):738-45. doi: 10.1165/rcmb.2012-0088OC. Epub 2012 Aug 3.
PubMed 22865623
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Chemical and Microbiological Heterogeneity Throughout Explanted Cystic Fibrosis Lung Specimens
- ClinicalTrials.gov ID
- NCT02128711
- Acronym / sponsor ID
- PACCS-2018-27376
- Conditions
- Cystic Fibrosis
- Keywords
- lung, cystic fibrosis, bacteria, positive diagnosis of CF,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 May 2014 (estimated)
- 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.
There is plenty of evidence to suggest that the lung is not uniform. The internal surface area is 30 times that of skin, and the different bronchioles/bronchi/alveoli differ greatly in blood perfusion, temperature, oxygen tension, and pH. Also, particularly in the context of respiratory disease, notable differences are present in the structure of epithelial cells, cilia, production of mucus, and inflammatory/immune responses. All of these factors are known to impact the physiology of bacteria, yet, there is very little understanding of how they impact a) the presence/absence of particular bacterial species throughout the respiratory tract, or b) the metabolic processes used by these bacteria within the human host environment. A greater understanding of the relationships between environmental (chemical) gradients in the lungs of diseased patients (particularly those with cystic fibrosis) and the microbial communities that are present may lead to novel hypotheses about manipulation of the respiratory environment for therapeutic benefit. To investigate this further, the investigators propose to use explanted lung specimens from cystic fibrosis patients to test the following hypothesis:
Hypothesis: In patients with cystic fibrosis, bacterial community composition, metabolism and environmental chemistry will vary depending on their spatial location within the airways.
Detailed description
To study this in greater detail, the investigators propose to study explanted tissue of CF patients that are scheduled to undergo single or double lung transplant surgery as a late-stage disease therapeutic strategy. This population will be limited to the Adult CF clinic, as pediatric subjects are rarely candidates for lung transplantation. The Adult CF Clinic performs upwards of 20 surgeries per year, and tissue that is explanted is typically discarded. Using this tissue, the investigators propose the following objectives:
- Use 16S culture-independent sequencing to characterize the spatial distribution of bacterial pathogens throughout the lungs of cystic fibrosis patients. Lungs will be dissected into 5 separate lobes, and mucus material will be collected, homogenized, and processed for bacterial species identification.
- Perform detailed analysis of specific gene expression throughout the respiratory tract that will serve as a proxy of environmental conditions found there. Using the same approach in Aim 1, bacterial mRNA will be extracted using established procedures. A subset of environmentally-specific genes will be detected to provide a readout of bacterial metabolism in use within the CF lung environment.
- Use in situ hybridization imaging to visualize the spatial distribution of specific bacteria and their gene expression profiles (informed by data generated in objectives 1 and 2). The bacteria and gene candidates identified/studied in Aims 1 and Aims 2 will then be subject to analysis using in situ hybridization imaging. Tissue will be processed using microtomy and fluorescent probes will be applied to image the spatial distribution of specific bacterial species and their metabolisms throughout the respiratory tract.
Information collected in these three objectives will then be paired with patient data (age, genotype, prior medical treatments, clinical microbiology data) to generate better working models of late-stage disease in CF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will include those undergoing single or double lung transplantation as part of their normally scheduled therapy for cystic fibrosis disease.
Key inclusion criteria (4 listed)
- diagnosis of cystic fibrosis
- eligible for lung transplantation
- exhausted other available therapies without success
- informed consent
Key exclusion criteria (1 listed)
- there are no exclusion criteria
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
Composition of bacterial communities throughout an explanted lung
Time frame: Entire study (3 years)
16S culture-independent sequencing will be used to characterize the spatial distribution of bacterial pathogens throughout the lungs of cystic fibrosis patients. Explanted lung specimens will be dissected into 5 separate lobes, and mucus material will be collected, homogenized, and processed for bacterial species identification.
1 secondary outcome
Levels of bacterial gene expression
Time frame: Entire study (3 years).
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 14 Oct 2025.
- Background: PubMed 23963183Hunter RC, Asfour F, Dingemans J, Osuna BL, Samad T, Malfroot A, Cornelis P, Newman DK. Ferrous iron is a significant component of bioavailable iron in cystic fibrosis airways. mBio. 2013 Aug 20;4(4):e00557-13. doi: 10.1128/mBio.00557-13.
- Background: PubMed 22865623Hunter RC, Klepac-Ceraj V, Lorenzi MM, Grotzinger H, Martin TR, Newman DK. Phenazine content in the cystic fibrosis respiratory tract negatively correlates with lung function and microbial complexity. Am J Respir Cell Mol Biol. 2012 Dec;47(6):738-45. doi: 10.1165/rcmb.2012-0088OC. Epub 2012 Aug 3.
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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.
Ryan C Hunter, PhD principal investigator
University of Minnesota Medical School (Microbiology)
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 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 14 Oct 2025. 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?
Composition of bacterial communities throughout an explanted lung (time frame: Entire study (3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128711, which also lists 2 linked publications.
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 14 Oct 2025.