Cystic Fibrosis (CF)NCT02778750
Evaluation Of The Pan-microbiome and Host Immune Response in CF
An observational study of Cystic Fibrosis (CF), run by NYU Langone Health at 1 site in United States.
Trial summary
Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic Fibrosis patients to explore microbiome features that are associated with an inflammatory phenotype. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- Two-Bronchoscope Technique
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2015to 12 Mar 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multicenter study to create a longitudinal cohort of adult CF subjects recruited from NYU and Columbia. A subgroup of subjects will be selected for a more invasive assessment of the lung microbiome with research bronchoscopy.
Who may be able to join
- CF diagnosis
- able to produce sputum
- no recent (one month) exacerbation defined as physician treatment with antibiotics for ≥ 7days
- FEV1 ≥ 30% of predicted.
Who cannot join
- Initiation of any new chronic therapy (e.g., ibuprofen, aerosolized rhDNase, hypertonic saline, azithromycin, tobramycin inhalation solution, aztreonam inhalation solution, ivacaftor) within 8 weeks prior to enrolment
- introduction of vitamins or proton pump inhibitors within 8 weeks prior to enrolment
- use of new investigational therapy within 4 weeks
- current smoker; use of oral corticosteroids
- Initiation of treatment or change in regimen for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria within 8 weeks.
- liver enzymes > 3 times the upper limit
Show all 12Show fewer
- pregnancy
- Additional Exclusion Criteria for Bronchoscopy Subgroup (Aims 2 and 3):
- FEV1 < 50% of predicted.
- Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
- Significant renal disease (Creatinine Clearance < 30%).
- Severe malnutrition (BMI <18kg/m2)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Evaluation Of The Pan-microbiome and Host Immune Response in Cystic Fibrosis (CF)
Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic Fibrosis patients to explore microbiome features that are associated with an inflammatory phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome are associated with host inflammatory responses.
While chronic and polymicrobial airway colonization are commonly recognized in cystic fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be three approaches to understanding inflammatory responses; 1) a longitudinal assessment of temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison of the regional differences in airway microbiome between lung segments with more versus less disease; 3) evaluation of functional aspects of the lung microbiome.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- Two-Bronchoscope Technique
- Keywords
- Cystic Fibrosis (CF)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-Bronchoscope TechniqueProcedure or surgery
Used to validate the use of sputum to sample the lower airway microbiome
| Study group | Role | What they receive |
|---|---|---|
| Stable Group | Not described Receives: Procedure: Two-Bronchoscope Technique | |
| Rapid Decliner Group | Not described Receives: Procedure: Two-Bronchoscope Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Oral Inflammatory markers
Measured: Baseline, 6 Months
Changes in Sputum Inflammatory Markers measured using research bronchoscopy
Measured: Baseline, 6 Months
Changes in Gut Microbiome
Measured: Baseline, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start5 Jun 2015
- Primary completion16 Jun 2017
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leopoldo Segal, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778750
- Sponsor's protocol ID
- 14-01692
- Status last verified
- Jul 2023
- First submitted
- 17 May 2016
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Pan-microbiome and Host Immune Response in Cystic Fibrosis (CF)
- ClinicalTrials.gov ID
- NCT02778750
- Acronym / sponsor ID
- 14-01692
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Cystic Fibrosis (CF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Jun 2015 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 20 May 2016 (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.
Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic Fibrosis patients to explore microbiome features that are associated with an inflammatory phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome are associated with host inflammatory responses.
While chronic and polymicrobial airway colonization are commonly recognized in cystic fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be three approaches to understanding inflammatory responses; 1) a longitudinal assessment of temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison of the regional differences in airway microbiome between lung segments with more versus less disease; 3) evaluation of functional aspects of the lung microbiome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable Group | – | Procedure: Two-Bronchoscope Technique |
| Rapid Decliner Group | – | Procedure: Two-Bronchoscope Technique |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multicenter study to create a longitudinal cohort of adult CF subjects recruited from NYU and Columbia. A subgroup of subjects will be selected for a more invasive assessment of the lung microbiome with research bronchoscopy.
Key inclusion criteria (4 listed)
- CF diagnosis
- able to produce sputum
- no recent (one month) exacerbation defined as physician treatment with antibiotics for ≥ 7days
- FEV1 ≥ 30% of predicted.
Key exclusion criteria (12 listed)
- Initiation of any new chronic therapy (e.g., ibuprofen, aerosolized rhDNase, hypertonic saline, azithromycin, tobramycin inhalation solution, aztreonam inhalation solution, ivacaftor) within 8 weeks prior to enrolment
- introduction of vitamins or proton pump inhibitors within 8 weeks prior to enrolment
- use of new investigational therapy within 4 weeks
- current smoker; use of oral corticosteroids
- Initiation of treatment or change in regimen for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria within 8 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-Bronchoscope TechniqueUsed to validate the use of sputum to sample the lower airway microbiome | Procedure or surgery | Rapid Decliner Group, Stable Group |
Primary outcome
Changes in Oral Inflammatory markers
Time frame: Baseline, 6 Months
Changes in Sputum Inflammatory Markers measured using research bronchoscopy
Time frame: Baseline, 6 Months
Changes in Gut Microbiome
Time frame: Baseline, 6 Months
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 11 Jul 2023.
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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.
Leopoldo Segal principal investigator
New York University Medical School
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 (CF), run by NYU Langone Health 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 12 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 11 Jul 2023. 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?
Changes in Oral Inflammatory markers (time frame: Baseline, 6 Months). The study lists 3 primary outcomes in all. 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 11 Jul 2023.