Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs

Cystic Fibrosis Clinical Trial

Official title:

Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590330
• Other study ID #: X07-10-0407
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: May 12, 2011
• Start date: October 2007
• Est. completion date: March 2009

Study information

• Verified date: May 2011
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information. Traditional culture methods of throat swab and sputum samples can only identify the most prevalent bacteria in samples, those of which there are over about 5 million bacteria per teaspoon. A recently developed method has been found to be more sensitive and can detect up to several hundred bacterial species in throat swab or sputum sample of individual CF patients.

Description:

This study does not include testing of any investigational drugs and this is a noninvasive study requiring only a sputum/swab sample paired with information contained in the routine clinic letters and laboratory results your CF physicians obtain at your regular clinic visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• Between the ages of 1-16 upon enrollment

• Diagnosis of Cystic Fibrosis

Exclusion Criteria:

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF).		2 years	No