Cystic FibrosisNCT05088447
A Study to Investigate Cystic Fibrosis Pulmonary Exacerbations and the Lung Microbiome
An observational study of Cystic Fibrosis, run by Stanford University at 1 site in United States.
Trial summary
The present application proposes to study the role the composition of the pediatric CF airway microbiota plays in frequent pulmonary exacerbations in pediatric CF patients. In order to accomplish this goal the dynamics of the composition of the CF airway microbiota in two distinct subsets of pediatric patients with CF… Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Mar 2017
- 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 Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: For the "Pulmonary Exacerbation Cohort," recruitment will be of cystic fibrosis pediatric patients with 3 or more hospital admissions with an admitting diagnosis of pulmonary exacerbation, requiring IV antibiotics, within the 12 month period prior to study enrollment, irrespective of race or ethnicity. This cohort will be matched with a "Clinically Stable Disease Cohort" which is matched by age, gender and CF genotype, irrespective of race or ethnicity. Ages recruited will be children, adolescents and young adults with Cystic Fibrosis from age 0-22 years.
Who may be able to join
- Diagnosis of CF (: a. One or more clinical features of CF AND (b or c); b. Sweat chloride > 60 mEq/L; c. Two known CF mutations)
- 3 or more admissions with an admitting diagnosis of pulmonary exacerbation, requiring IV antibiotics, within the 12 month period prior to study enrollment.
- Clinically Stable Disease Cohort
- Diagnosis of CF (: a. One or more clinical features of CF AND (b or c); b. Sweat chloride > 60 mEq/L; c. Two known CF mutations)
- Age and gender matched to Pulmonary Exacerbation Cohort
- No hospitalizations with an admitting diagnosis of pulmonary exacerbation, within the 12 month period prior to study enrollment.
Who cannot join
- History of intolerance or inability to tolerate the induced sputum protocol.
- History of organ transplantation.
- Any patient that in discretion of the investigators is not suitable.
- Any clinically unstable participants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cystic Fibrosis Clinic, LPCH
Palo Alto, California, 94304
About this study
The present application proposes to study the role the composition of the pediatric CF airway microbiota plays in frequent pulmonary exacerbations in pediatric CF patients.
In order to accomplish this goal the dynamics of the composition of the CF airway microbiota in two distinct subsets of pediatric patients with CF will be characterized, those with frequent pulmonary exacerbations and clinically stable children. Clinical measures of pulmonary function, patient reported symptoms, sleep quality, and antibiotic usage will be recorded, and these findings will be correlated with the lung microbiota data.
This strategy promises to identify the key characteristics of the pediatric CF microbiota, which can in turn be used as noninvasive markers to identify those patients at a higher risk for experiencing repeated pulmonary exacerbations.
Read the detailed description
Acute pulmonary exacerbations cause significant morbidity in the lives of children with cystic fibrosis (CF). As the etiologies of exacerbations continue to be defined, characterizing the role of the pulmonary microbiota in chronic infection and inflammation provides an opportunity for insight into the pathophysiology of CF.
This point is particularly true for a subset of pediatric CF patients with severe disease and frequent exacerbations.
The present application proposes to test the overall hypothesis that the composition of the pediatric CF airway microbiota plays an etiologic role in frequent pulmonary exacerbations in pediatric CF patients. To address the working hypothesis, next-generation sequencing based 16S rRNA sequencing will be undertaken to dissect the microbiome of pediatric CF patients subject to frequent pulmonary exacerbations, relative to the microbiome in clinically stable CF patients. This strategy promises to more specifically and definitively identify the key characteristics of the pediatric CF microbiota that are associated with the occurrence of exacerbations. Record clinical measures of pulmonary function, patient reported symptoms, sleep quality, and antibiotic usage, and correlate these findings with the lung microbiota data. This insight would in turn provide noninvasive biomarkers to identify those patients at a higher risk for experiencing repeated pulmonary exacerbations, which over the long-term significantly compromise lung function.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stable Disease | 15 control "stable disease" participants | |
| Frequent Exacerbation Cohort | 15 experimental "frequent exacerbation cohort" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung microbiome profile
Lung microbiome in Cystic Fibrosis pulmonary exacerbations
Measured: Baseline - 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study startFeb 2015
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Change in research plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Tracy, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088447
- Sponsor's protocol ID
- 32509
- Status last verified
- Oct 2021
- First submitted
- 18 May 2015
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate Cystic Fibrosis Pulmonary Exacerbations and the Lung Microbiome
- ClinicalTrials.gov ID
- NCT05088447
- Acronym / sponsor ID
- 32509
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in research plan
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Oct 2021 (actual)
- 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.
The present application proposes to study the role the composition of the pediatric CF airway microbiota plays in frequent pulmonary exacerbations in pediatric CF patients.
In order to accomplish this goal the dynamics of the composition of the CF airway microbiota in two distinct subsets of pediatric patients with CF will be characterized, those with frequent pulmonary exacerbations and clinically stable children. Clinical measures of pulmonary function, patient reported symptoms, sleep quality, and antibiotic usage will be recorded, and these findings will be correlated with the lung microbiota data.
This strategy promises to identify the key characteristics of the pediatric CF microbiota, which can in turn be used as noninvasive markers to identify those patients at a higher risk for experiencing repeated pulmonary exacerbations.
Detailed description
Acute pulmonary exacerbations cause significant morbidity in the lives of children with cystic fibrosis (CF). As the etiologies of exacerbations continue to be defined, characterizing the role of the pulmonary microbiota in chronic infection and inflammation provides an opportunity for insight into the pathophysiology of CF.
This point is particularly true for a subset of pediatric CF patients with severe disease and frequent exacerbations.
The present application proposes to test the overall hypothesis that the composition of the pediatric CF airway microbiota plays an etiologic role in frequent pulmonary exacerbations in pediatric CF patients. To address the working hypothesis, next-generation sequencing based 16S rRNA sequencing will be undertaken to dissect the microbiome of pediatric CF patients subject to frequent pulmonary exacerbations, relative to the microbiome in clinically stable CF patients. This strategy promises to more specifically and definitively identify the key characteristics of the pediatric CF microbiota that are associated with the occurrence of exacerbations. Record clinical measures of pulmonary function, patient reported symptoms, sleep quality, and antibiotic usage, and correlate these findings with the lung microbiota data. This insight would in turn provide noninvasive biomarkers to identify those patients at a higher risk for experiencing repeated pulmonary exacerbations, which over the long-term significantly compromise lung function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable Disease | – | –15 control "stable disease" participants |
| Frequent Exacerbation Cohort | – | –15 experimental "frequent exacerbation cohort" |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- For the "Pulmonary Exacerbation Cohort," recruitment will be of cystic fibrosis pediatric patients with 3 or more hospital admissions with an admitting diagnosis of pulmonary exacerbation, requiring IV antibiotics, within the 12 month period prior to study enrollment, irrespective of race or ethnicity. This cohort will be matched with a "Clinically Stable Disease Cohort" which is matched by age, gender and CF genotype, irrespective of race or ethnicity. Ages recruited will be children, adolescents and young adults with Cystic Fibrosis from age 0-22 years.
Key inclusion criteria (6 listed)
- Diagnosis of CF (: a. One or more clinical features of CF AND (b or c); b. Sweat chloride > 60 mEq/L; c. Two known CF mutations)
- 3 or more admissions with an admitting diagnosis of pulmonary exacerbation, requiring IV antibiotics, within the 12 month period prior to study enrollment.
- Clinically Stable Disease Cohort
- Diagnosis of CF (: a. One or more clinical features of CF AND (b or c); b. Sweat chloride > 60 mEq/L; c. Two known CF mutations)
- Age and gender matched to Pulmonary Exacerbation Cohort
Key exclusion criteria (4 listed)
- History of intolerance or inability to tolerate the induced sputum protocol.
- History of organ transplantation.
- Any patient that in discretion of the investigators is not suitable.
- Any clinically unstable participants.
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
Change in lung microbiome profile
Time frame: Baseline - 3 years
Lung microbiome in Cystic Fibrosis pulmonary exacerbations
Results and safety
The study was stopped early (reason given: Change in research plan). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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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.
Michael Tracy, MD principal investigator
Stanford University
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 Stanford University 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Oct 2021. 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 was stopped early (reason given: Change in research plan). Results are not available in the source record.
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?
Change in lung microbiome profile (time frame: Baseline - 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 22 Oct 2021.