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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Throat Swab

Infants who have been diagnosed with cystic fibrosis

Throat Swab

Intervention Type PROCEDURE

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.

Interventions

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Throat Swab

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.

Intervention Type PROCEDURE

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