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

This study has been completed.
Sponsor:
Collaborator:
Harvard University
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00590330
First received: December 26, 2007
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • To identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

sputum or throat culture


Enrollment: 55
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

pulmonary clinic

Criteria

Inclusion Criteria:

  • Between the ages of 1-16 upon enrollment
  • Diagnosis of Cystic Fibrosis

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590330

Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Harvard University
Investigators
Principal Investigator: Thomas Martin, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Thomas Martin, MD, Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT00590330     History of Changes
Other Study ID Numbers: X07-10-0407
Study First Received: December 26, 2007
Last Updated: May 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014