Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP

January 21, 2024 updated by: Cheng Lei, The First Affiliated Hospital with Nanjing Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal polyp size after glucocorticosteroid
Time Frame: 17days
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
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Lei Cheng, The First Affiliated Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 22, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2032

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 21, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microbiome and CRSwNP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All the individual participant data only available to reasearchers participated in this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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