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

Withdrawn

• Conditions: Cystic Fibrosis
• Interventions: Procedure: Throat Swab

• Registration Number: NCT00977158
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-14
• Study First Posted: 2009-09-15
• Study Start: 2011-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Throat Swab	Throat Swab	Infants who have been diagnosed with cystic fibrosis

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Floating Hospital for Children at Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States