Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 1:29 PM
Study NCT ID:
NCT00977158
Status:
WITHDRAWN
Last Update Posted:
2015-03-18
First Post:
2009-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D011552', 'term': 'Pseudomonas Infections'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], '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'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No problems with planned study- insufficient funding for this study to proceed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2009-09-14', 'studyFirstSubmitQcDate': '2009-09-14', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the microbial ecology and changes in bacterial diversity of the oropharynx in a cohort of children with CF during the first year of life using 16S rRNA sequence analysis', 'timeFrame': '6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age'}, {'measure': 'To describe the clinical variables that may be associated with changes in microbial ecology in children with cystic fibrosis over the first year of life', 'timeFrame': '6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age'}, {'measure': 'To explore changes in the microbial ecology of the oropharynx in conjunction with Staphylococcus aureus colonization in children with CF', 'timeFrame': '6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'Microbiota', 'upper respiratory tract', '16S rRNA sequence analysis', 'Staphylococcus aureus', 'Pseudomonas aeruginosa', 'Burkholderia cepacia', 'Haemophilus influenzae', 'Streptococcus pneumoniae'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order to chart any changes in the bacterial populations of the respiratory tract. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities. This study will provide preliminary data on whether probiotics can eradicate the colonization of the respiratory tract by pathogenic bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants with cystic fibrosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects, newborn to age 3 months\n* Have a diagnosis of cystic fibrosis (Diagnosis of CF will be based on either a positive sweat chloride of \\>60 mEq/L or the identification of two detectable mutations associated with CF\n* Parent/guardian plans to have follow-up care for approximately one year at designated CF clinic\n* Parent/guardian provides informed consent to participate in the study\n\nExclusion Criteria:\n\n* Contraindications for obtaining oropharyngeal swabs'}, 'identificationModule': {'nctId': 'NCT00977158', 'briefTitle': 'Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life', 'orgStudyIdInfo': {'id': '8851'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Throat Swab', 'description': 'Infants who have been diagnosed with cystic fibrosis', 'interventionNames': ['Procedure: Throat Swab']}], 'interventions': [{'name': 'Throat Swab', 'type': 'PROCEDURE', 'description': 'Swabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the throat and processed for bacterial cultures and for bacterial DNA extraction.', 'armGroupLabels': ['Throat Swab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Floating Hospital for Children at Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Patricia L Hibberd, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Patricia L. Hibberd, MD, PhD', 'oldOrganization': 'Tufts Medical Center'}}}}