Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-18 @ 3:53 AM
Study NCT ID:
NCT02063932
Status:
UNKNOWN
Last Update Posted:
2014-02-17
First Post:
2014-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The metagenome was obtained from biopsy specimen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-02-14', 'studyFirstSubmitDate': '2014-01-29', 'studyFirstSubmitQcDate': '2014-02-14', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The operational taxonomy units in gastric mucosal microbiome', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The diagnostic accuracy of endomicroscopy compared to pathology.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mucosal microbiome', 'H.pylori', 'intestinal metaplasia', 'gastric neoplasia', 'endomicroscopy'], 'conditions': ['Mucosal Microbiome', 'H.Pylori', 'Intestinal Metaplasia', 'Gastric Neoplasia']}, 'descriptionModule': {'briefSummary': 'There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.', 'detailedDescription': 'The gastric mucosal microbiome plays a pivotal role in a series of diseases, such as the H.pylori infection. We hypothesized that mucosal patterns, here visualized by confocal endomicroscopy, may constitute specific microbiome niches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients scheduled for gastroendoscopy examination\n* Aged between 18 and 80 years old\n\nExclusion criteria:\n\n* Antibiotic, probiotic or prebiotic usage within 2months\n* Esophageal, gastric or duodenal cancer or other malignancy\n* History of upper GI tract surgery\n* Coagulopathy or bleeding disorders\n* Allergy to fluorescein sodium\n* Pregnant or breast-feeding (for females)\n* Impaired renal function'}, 'identificationModule': {'nctId': 'NCT02063932', 'briefTitle': 'Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome', 'orgStudyIdInfo': {'id': '2014SDU-QILU-G02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endomicroscopy', 'interventionNames': ['Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing']}], 'interventions': [{'name': 'endomicroscopy, targeted biopsy and 16s rRNA gene sequencing', 'type': 'OTHER', 'armGroupLabels': ['endomicroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqing Li, MD. PhD.', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-531-82169236', 'phoneExt': '82169508'}, {'name': 'Yanqing Li, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ming Li, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'wei wei, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}