Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life

Study Overview
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Brief Summary
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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.

Official Title
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Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Procedure: Throat Swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Contraindications for obtaining oropharyngeal swabs

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Throat Swab<br>Infants who have been diagnosed with cystic fibrosis | Procedure: Throat Swab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Microbiota, upper respiratory tract, 16S rRNA sequence analysis, Staphylococcus aureus, Pseudomonas aeruginosa, Burkholderia cepacia, Haemophilus influenzae, Streptococcus pneumoniae