Clinical trial NCT00977158: Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life
Official title: Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Microbiota
upper respiratory tract
16S rRNA sequence analysis
Staphylococcus aureus
Pseudomonas aeruginosa
Burkholderia cepacia
Haemophilus influenzae
Streptococcus pneumoniae
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2009-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with cystic fibrosis

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
measure: 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
timeFrame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
measure: To explore changes in the microbial ecology of the oropharynx in conjunction with Staphylococcus aureus colonization in children with CF
timeFrame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Floating Hospital for Children at Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Patricia L Hibberd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: