Cystic FibrosisNCT00590330
Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs
An observational study of Cystic Fibrosis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2009
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: pulmonary clinic
Who may be able to join
- Between the ages of 1-16 upon enrollment
- Diagnosis of Cystic Fibrosis
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information. Traditional culture methods of throat swab and sputum samples can only identify the most prevalent bacteria in samples, those of which there are over about 5 million bacteria per teaspoon. A recently developed method has been found to be more sensitive and can detect up to several hundred bacterial species in throat swab or sputum sample of individual CF patients.
Read the detailed description
This study does not include testing of any investigational drugs and this is a noninvasive study requiring only a sputum/swab sample paired with information contained in the routine clinic letters and laboratory results your CF physicians obtain at your regular clinic visits.
- 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.
To identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionMar 2009
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 Boston Children's HospitalThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Investigators
- Thomas Martin, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590330
- Sponsor's protocol ID
- X07-10-0407
- Status last verified
- May 2011
- First submitted
- 26 Dec 2007
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs
- ClinicalTrials.gov ID
- NCT00590330
- Acronym / sponsor ID
- X07-10-0407
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Jan 2008 (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.
The purpose of this study is to identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information. Traditional culture methods of throat swab and sputum samples can only identify the most prevalent bacteria in samples, those of which there are over about 5 million bacteria per teaspoon. A recently developed method has been found to be more sensitive and can detect up to several hundred bacterial species in throat swab or sputum sample of individual CF patients.
Detailed description
This study does not include testing of any investigational drugs and this is a noninvasive study requiring only a sputum/swab sample paired with information contained in the routine clinic letters and laboratory results your CF physicians obtain at your regular clinic visits.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pulmonary clinic
Key inclusion criteria (2 listed)
- Between the ages of 1-16 upon enrollment
- Diagnosis of Cystic Fibrosis
Key exclusion criteria (1 listed)
- None
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
To identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF).
Time frame: 2 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 13 May 2011.
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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.
Thomas Martin, MD principal investigator
Boston Children's Hospital
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 Boston Children's Hospital 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 2 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 13 May 2011. 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?
To identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF). (time frame: 2 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 13 May 2011.