Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Nasal polyp size after glucocorticosteroid [Срок оценки: 17days]
• endoscopic evidence of returned polyposis [Срок оценки: 3 years]

Критерии участия

Критерии включения

\- 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

Критерии исключения

\- 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06231004 · Microbiome and CRSwNP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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