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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00977158
• Other study ID #: 8851
• Status: Withdrawn
• Phase: N/A
• First received: September 14, 2009
• Last updated: March 17, 2015
• Start date: May 2011

Study information

• Verified date: March 2015
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Floating Hospital for Children at Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No