Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-03 @ 3:01 PM
Study NCT ID:
NCT03335202
Status:
UNKNOWN
Last Update Posted:
2017-11-17
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Analysis of Respiratory and Intestinal Microbiome 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-28', 'size': 436876, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-10-08T02:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sputum, throat swab and stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-15', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-11-03', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'respiratory microbiome', 'timeFrame': '24 weeks', 'description': 'abundance \\[operational taxonomic units\\]'}, {'measure': 'intestinal microbiome', 'timeFrame': '24 weeks', 'description': 'abundance \\[operational taxonomic units\\]'}], 'secondaryOutcomes': [{'measure': 'Forced Exspiratory Volume FEV1 [%pred]', 'timeFrame': '24 weeks', 'description': 'performed by bodyplethmograph'}, {'measure': 'weight (kg)', 'timeFrame': '24 weeks', 'description': 'for children, height (cm) is also recorded'}, {'measure': 'Quality of life [score]', 'timeFrame': '24 weeks', 'description': 'Cystic Fibrosis Questionnaire Revised CFQ-R \\[score 0-100, higher scores indicating better Quality of Life\\]'}, {'measure': 'Quality of life [score]', 'timeFrame': '24 weeks', 'description': 'Kiel Questionnaire Kiel-Q \\[score 0-100, higher scores indicating hetter Quality of Life\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory and intestinal microbiome', 'antibiotic therapy', 'cftr modifier', 'diversity'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Respiratory und intestinal microbiome will bei analyzed during a period of 6 months. In a retrospective analysis it will be looked for correlations between microbiome and cf therapy (e.g. inhaled and systemic antibiotics, cftr modifiers, proton pump Inhibitors, enzymes, nutritional habits), clinical status and self reported outcome.', 'detailedDescription': 'DNA will be isolated from sputum, throat swabs and stool samples and used for the generation of microbial profiles. Both bacterial and fungal profiles will be analyzed by next generation sequencing.\n\nClinical outcome parameters (lung function test, weight, calprotectin, elastase, blood parameters, self reported outcome) will be recorded and analyzed along with medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult cf patients treated in Adult Cystic Fibrosis Center, Klinik für Innere Medizin I, UKSH Kiel', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject has confirmed diagnosis of cystic fibrosis (sweat chloride \\>60mmol/l and/or 2 mutations in the cftr gene known to cause cystic fibrosis)\n* subject is able to perform informed consent\n\nExclusion Criteria:\n\n* inability to give informed consent\n* antibiotic therapy in the last 4 weeks prior to study start (exception: long term azithromycin therapy, long term antistaphylococcal therapy, long term inhaled antibiotics)'}, 'identificationModule': {'nctId': 'NCT03335202', 'briefTitle': 'Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Kiel'}, 'officialTitle': 'Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'B495/16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cf patients at the cf centre Kiel', 'description': 'microbiome of cf patients at the cf centre Kiel will be analyzed and correlated to standard cf care.', 'interventionNames': ['Diagnostic Test: analysis of microbiome']}], 'interventions': [{'name': 'analysis of microbiome', 'type': 'DIAGNOSTIC_TEST', 'description': 'microbial profiling by next generation sequencing', 'armGroupLabels': ['cf patients at the cf centre Kiel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ingrid CF Bobis, MD', 'role': 'CONTACT', 'email': 'ingrid.bobis@uksh.de', 'phone': '+49-1578-8209311'}, {'name': 'Andre Franke, PhD', 'role': 'CONTACT', 'email': 'a.franke@mucosa.de', 'phone': '+49-431-500-15110'}, {'name': 'Stefan Schreiber, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Burkhard Bewig, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andre Franke, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Corinna Bang, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Klinik für Innere Medizin I, UKSH KIel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'centralContacts': [{'name': 'Ingrid CF Bobis, MD', 'role': 'CONTACT', 'email': 'ingrid.bobis@uksh.de', 'phone': '+49-1578-8209311'}, {'name': 'Andre Franke, PhD', 'role': 'CONTACT', 'email': 'a.franke@mucosa.de', 'phone': '+49-431-500-15110'}], 'overallOfficials': [{'name': 'Ingrid CF Bobis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Innere Medizin I, UKSH Kiel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kiel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med., Oberärztin für Pneumologie, Head of Adult CF Centre UKSH Kiel, Klinik für Innere Medizin I UKSH Kiel', 'investigatorFullName': 'Ingrid Bobis', 'investigatorAffiliation': 'University of Kiel'}}}}