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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590330
First Posted: January 10, 2008
Last Update Posted: May 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Harvard University
Information provided by:
Boston Children’s Hospital
  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 Boston Children’s Hospital:

Primary Outcome Measures:
  • To identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF). [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590330


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

Responsible Party: Thomas Martin, MD, Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT00590330     History of Changes
Other Study ID Numbers: X07-10-0407
First Submitted: December 26, 2007
First Posted: January 10, 2008
Last Update Posted: May 13, 2011
Last Verified: May 2011

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