Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT00954018
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2009-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microbial Community Composition and Metabolism in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'throat swabs or sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2009-08-05', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cystic fibrosis patients will be contacted during clinical care visits and inpatient hospitalizations.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of Cystic Fibrosis\n* 2 to 55 years of age\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00954018', 'briefTitle': 'Microbial Community Composition and Metabolism in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Respiratory Microbial Community Composition and Metabolism in Cystic Fibrosis', 'orgStudyIdInfo': {'id': '09-04-018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cystic Fibrosis patient during outpatient clinic visit'}, {'label': 'Cystic Fibrosis patients during hospitalization'}, {'label': 'CF patients about to have sinus surgery and bronchoscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hosptital, Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Thomas Martin', 'investigatorAffiliation': "Boston Children's Hospital"}}}}