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Microbial Community Composition and Metabolism in Cystic Fibrosis

This study is currently recruiting participants.
Verified July 2017 by Thomas Martin, Boston Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00954018
First Posted: August 6, 2009
Last Update Posted: August 2, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Massachusetts Institute of Technology
Harvard Medical School
Information provided by (Responsible Party):
Thomas Martin, Boston Children's Hospital
  Purpose
Scientist have begun to realize that many types of bacteria often live together as a complex community, and the investigators wish to apply that idea to the bacteria in the respiratory system of people with Cystic Fibrosis (CF). It is possible that the survival of the many millions of bacteria in the CF lung depends on the production of special chemicals that might be made only by very few types of bacteria. If that is true, medicines that interfere with those chemicals could treat the lung infections that cause trouble for nearly all people with CF. The investigators wish to study the production of several potentially critical chemicals by the respiratory bacteria and to examine the effect of those chemicals on the makeup of the entire community of bacteria. To detect all the bacteria in that community, the investigators will use new methods that use bacterial genetic information and can detect hundreds of different types of bacteria in respiratory samples of individual CF patients.

Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Respiratory Microbial Community Composition and Metabolism in Cystic Fibrosis

Resource links provided by NLM:


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

Biospecimen Retention:   Samples Without DNA
throat swabs or sputum

Estimated Enrollment: 120
Study Start Date: August 2009
Groups/Cohorts
Cystic Fibrosis patient during outpatient clinic visit
Cystic Fibrosis patients during hospitalization
CF patients about to have sinus surgery and bronchoscopy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cystic fibrosis patients will be contacted during clinical care visits and inpatient hospitalizations.
Criteria

Inclusion Criteria:

  • confirmed diagnosis of Cystic Fibrosis
  • 2 to 55 years of age

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): NCT00954018


Locations
United States, Massachusetts
Children's Hosptital, Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Magen Lorenzi    617-335-6077    magen.lorenzi@childrens.harvard.edu   
Contact: Thomas Martin, MD    617-355-8754    thomas.martin@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Massachusetts Institute of Technology
Harvard Medical School
  More Information

Responsible Party: Thomas Martin, Assistant Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00954018     History of Changes
Other Study ID Numbers: 09-04-018
First Submitted: August 5, 2009
First Posted: August 6, 2009
Last Update Posted: August 2, 2017
Last Verified: July 2017

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