Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Clinical Trial

Official title:

A Study on the Correlation Between the Microbiome and Type 2 Inflammatory Diseases of Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06231004
• Other study ID #: Microbiome and CRSwNP
• Status: Not yet recruiting
• Start date: January 22, 2024
• Est. completion date: September 1, 2032

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Lei Cheng, Phd
• Phone: 0086-13776620807
• Email: chenglei[@]jsph.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2032
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
• Nasal Polyps
• Polyps

Intervention

Procedure:
• glucocorticosteroid and surgery
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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