Cystic FibrosisNCT00977158
Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life
An observational study of Cystic Fibrosis, run by Tufts Medical Center at 2 sites in United States.
Trial summary
The goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with CF. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Throat Swab
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to not given
- 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 day to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants with cystic fibrosis
Who may be able to join
- Male and female subjects, newborn to age 3 months
- Have a diagnosis of cystic fibrosis (Diagnosis of CF will be based on either a positive sweat chloride of >60 mEq/L or the identification of two detectable mutations associated with CF
- Parent/guardian plans to have follow-up care for approximately one year at designated CF clinic
- Parent/guardian provides informed consent to participate in the study
Who cannot join
- Contraindications for obtaining oropharyngeal swabs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
The goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order to chart any changes in the bacterial populations of the respiratory tract. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities. This study will provide preliminary data on whether probiotics can eradicate the colonization of the respiratory tract by pathogenic bacteria.
- Conditions
- Cystic Fibrosis
- Being tested
- Throat Swab
- Keywords
- Cystic Fibrosis, Microbiota, upper respiratory tract, 16S rRNA sequence analysis, Staphylococcus aureus, Pseudomonas aeruginosa, Burkholderia cepacia, Haemophilus influenzae, Streptococcus pneumoniae
- Medical subject headings
- Cystic Fibrosis, Staphylococcal Infections, Pseudomonas Infections, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Throat SwabProcedure or surgery
Swabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the throat and processed for bacterial cultures and for bacterial DNA extraction.
| Study group | Role | What they receive |
|---|---|---|
| Throat Swab | Infants who have been diagnosed with cystic fibrosis Receives: Procedure: Throat Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the microbial ecology and changes in bacterial diversity of the oropharynx in a cohort of children with CF during the first year of life using 16S rRNA sequence analysis
Measured: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
To describe the clinical variables that may be associated with changes in microbial ecology in children with cystic fibrosis over the first year of life
Measured: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
To explore changes in the microbial ecology of the oropharynx in conjunction with Staphylococcus aureus colonization in children with CF
Measured: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startMay 2011
Why it stopped: No problems with planned study- insufficient funding for this study to proceed.
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Patricia L Hibberd, MD, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977158
- Sponsor's protocol ID
- 8851
- Status last verified
- Mar 2015
- First submitted
- 14 Sep 2009
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life
- ClinicalTrials.gov ID
- NCT00977158
- Acronym / sponsor ID
- 8851
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Microbiota, upper respiratory tract, 16S rRNA sequence analysis, Staphylococcus aureus, Pseudomonas aeruginosa, Burkholderia cepacia, Haemophilus influenzae
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No problems with planned study- insufficient funding for this study to proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- May 2011
- First posted
- 15 Sep 2009 (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 goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order to chart any changes in the bacterial populations of the respiratory tract. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities. This study will provide preliminary data on whether probiotics can eradicate the colonization of the respiratory tract by pathogenic bacteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Throat Swab | – | Procedure: Throat SwabInfants who have been diagnosed with cystic fibrosis |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with cystic fibrosis
Key inclusion criteria (4 listed)
- Male and female subjects, newborn to age 3 months
- Have a diagnosis of cystic fibrosis (Diagnosis of CF will be based on either a positive sweat chloride of >60 mEq/L or the identification of two detectable mutations associated with CF
- Parent/guardian plans to have follow-up care for approximately one year at designated CF clinic
- Parent/guardian provides informed consent to participate in the study
Key exclusion criteria (1 listed)
- Contraindications for obtaining oropharyngeal swabs
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 |
|---|---|---|
| Throat SwabSwabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the throat and processed for bacterial cultures and for bacterial DNA extraction. | Procedure or surgery | Throat Swab |
Primary outcome
To characterize the microbial ecology and changes in bacterial diversity of the oropharynx in a cohort of children with CF during the first year of life using 16S rRNA sequence analysis
Time frame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
To describe the clinical variables that may be associated with changes in microbial ecology in children with cystic fibrosis over the first year of life
Time frame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
To explore changes in the microbial ecology of the oropharynx in conjunction with Staphylococcus aureus colonization in children with CF
Time frame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
Patricia L Hibberd, MD, PhD principal investigator
Tufts Medical Center
2 sites 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 Tufts Medical Center at 2 sites 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: withdrawn, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 withdrawn before enrolling participants, so there are no results.
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 characterize the microbial ecology and changes in bacterial diversity of the oropharynx in a cohort of children with CF during the first year of life using 16S rRNA sequence analysis (time frame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age). 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 18 Mar 2015.