Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP

NCT06231004 | Not Yet Recruiting

• 1 other identifier: Microbiome and CRSwNP
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Outcome Measures

Primary Outcomes (2)

• Nasal polyp size after glucocorticosteroid

  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

  17days

• endoscopic evidence of returned polyposis

  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

  3 years

Study Arms (1)

Experimental group

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

Procedure: glucocorticosteroid and surgery

Interventions

glucocorticosteroid and surgery PROCEDURE

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Patients in the First Affiliated Hospital, Nanjing Medical University and volunteering for this study

You may qualify if:

• \- 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

You may not qualify if:

• Healthy Volunteers:
• Only 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Collection of feces, saliva, plasma, nasal microorganisms， tonsil microorganisms, nasal exfoliated cells and nasal secretions

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Lei Cheng

  The First Affiliated Hospital, Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Lei Cheng, Phd

CONTACT

0086-13776620807; chenglei@jsph.org.cn

yingying zhang, MBBS

CONTACT

0086-17314458362; zhangyy@stu.njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor， PhD

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: January 22, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2032
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share