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Not yet recruitingNCT06231004Updated Jan 30, 2024

Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP

An observational study in Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
03

In context

Nasal Polyps

236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 100 across 47 observational studies indexed under Nasal Polyps.

Browse Nasal Polyps studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (oral or aerosol) and antileukotriene therapy for at least 4 weeks prior to or surgery

Exclusion criteria

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 and went in for septal correction. The rest of the criteria were the same

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Procedureglucocorticosteroid 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 17days

  2. 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

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — All the individual participant data only available to reasearchers participated in this study

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2024; primary completion for Sep 2026, 31 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2024
First posted
Jan 30, 2024
StartEst.
Jan 22, 2024
Primary completionEst.
Sep 1, 2026
CompletionEst.
Sep 1, 2032
Last update
Jan 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06231004
Responsible party
Cheng Lei (Professor, PhD, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Jan 30, 2024
Start date
Jan 22, 2024 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2032 (estimated)
Last update
Jan 30, 2024

Study contacts

Lei Cheng, Phd
Contact
chenglei@jsph.org.cn
0086-13776620807
yingying zhang, MBBS
Contact
zhangyy@stu.njmu.edu.cn
0086-17314458362
Lei Cheng
study director · The First Affiliated Hospital, Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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