Study Stopped
No problems with planned study- insufficient funding for this study to proceed.
Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life
1 other identifier
observational
N/A
1 country
2
Brief 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. 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.
Trial Health
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2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2009
CompletedFirst Posted
Study publicly available on registry
September 15, 2009
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedMarch 18, 2015
March 1, 2015
September 14, 2009
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
Study Arms (1)
Throat Swab
Infants who have been diagnosed with cystic fibrosis
Interventions
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.
Eligibility Criteria
Infants with cystic fibrosis
You may qualify if:
- 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
You may not qualify if:
- Contraindications for obtaining oropharyngeal swabs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia L Hibberd, MD, PhD
Tufts Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2009
First Posted
September 15, 2009
Study Start
May 1, 2011
Last Updated
March 18, 2015
Record last verified: 2015-03