Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT06231004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Collection of feces, saliva, plasma, nasal microorganisms， tonsil microorganisms, nasal exfoliated cells and nasal secretions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2032-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-21', 'studyFirstSubmitDate': '2024-01-21', 'studyFirstSubmitQcDate': '2024-01-21', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal polyp size after glucocorticosteroid', 'timeFrame': '17days', 'description': 'Patients who did not have a reduction of more than 1 polyp score based on the NPSS system after glucocorticoid therapy were defined as glucocorticoid nonresponders'}, {'measure': 'endoscopic evidence of returned polyposis', 'timeFrame': '3 years', 'description': 'endoscopic evidence of returned polyposis, together with 1 or more bothersome symptoms (nasal obstruction, rhinorrhea, headache/facial pain, smell abnormalities, and sleep disturbance/fatigue) lasting at least 1 week even after receiving appropriate intranasal GC treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)']}, 'descriptionModule': {'briefSummary': "Nasal microorganisms, exfoliated cells, nasal secretions, fetal microorganisms and blood were collected from patients with chronic sinusitis with nasal polyps before medication. Nasal polyp tissues of the patients were clamped for pathologic biopsy in the outpatient clinic. Methylprednisolone was then administered to the patients for 17 days, and the nasal microbial changes were observed after the administration of the drug. Patients underwent surgical treatment after the administration of the drug, and postoperative patients were followed up for a long period of time until polyp recurrence. During the follow-up, the microorganisms in the patients' postoperative nasal cavities were collected and the postoperative microbial changes were recorded", 'detailedDescription': 'In this study, we retrospectively collected pathologic paraffin specimens and patient information from previous cases of sinusitis with nasal polyps, and prospectively collected specimens from newly enrolled patients with nasal polyps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Patients in the First Affiliated Hospital, Nanjing Medical University and volunteering for this study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The diagnosis of CRSwNP was based on EPOS20201 ECRSwNP was defined as EO accounting for more than 27% of the total infiltration Subjects undergoing septoplasty due to anatomical variations served as controls Discontinuation of steroid (oral or aerosol) and antileukotriene therapy for at least 4 weeks prior to biopsy or surgery\n\nExclusion Criteria:\n\n\\- Exclude patients with a diagnosis of posterior maxillary sinus polyps, cystic fibrosis, allergic fungal sinusitis, primary ciliary dyskinesia, allergic rhinitis, immune deficiency, or coagulopathy Exclusion of patients with aspirin intolerance (AERD) Exclude smokers Exclude pregnant women\n\nHealthy Volunteers:\n\nOnly patients with deviated septum without any other nasal diseases served as a control group, and the participants in this group were not treated with corticosteroids and went in for septal correction. The rest of the criteria were the same'}, 'identificationModule': {'nctId': 'NCT06231004', 'briefTitle': 'Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Study on the Correlation Between the Microbiome and Type 2 Inflammatory Diseases of Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)', 'orgStudyIdInfo': {'id': 'Microbiome and CRSwNP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'Take glucocorticosteroid at once in the morning and use the following course of treatment: 6 tablets/day for 7 days-- 5 tablets/day for 2 days-- 4 tablets/day for 2 days-- 3 tablets/day for 2 days-- 2 tablets/day for 2 days-- 1 tablets/day for 2 days--surgery', 'interventionNames': ['Procedure: glucocorticosteroid and surgery']}], 'interventions': [{'name': 'glucocorticosteroid and surgery', 'type': 'PROCEDURE', 'description': 'Take glucocorticosteroid at once in the morning and use the following course of treatment: 6 tablets/day for 7 days-- 5 tablets/day for 2 days-- 4 tablets/day for 2 days-- 3 tablets/day for 2 days-- 2 tablets/day for 2 days-- 1 tablets/day for 2 days--surgery', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lei Cheng, Phd', 'role': 'CONTACT', 'email': 'chenglei@jsph.org.cn', 'phone': '0086-13776620807'}, {'name': 'yingying zhang, MBBS', 'role': 'CONTACT', 'email': 'zhangyy@stu.njmu.edu.cn', 'phone': '0086-17314458362'}], 'overallOfficials': [{'name': 'Lei Cheng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital, Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All the individual participant data only available to reasearchers participated in this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor， PhD', 'investigatorFullName': 'Cheng Lei', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}