The Effects of Exosomes in Otitis Media With Effusion

NCT05402267 | Unknown

• 1 other identifier: OME-2022
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

The particularity of adenoids, as a reservoir of bacterial pathogens and immune molecules, is known to be significantly involved in children with otitis media with effusion (OME). As an important carrier of intercellular substance transfer and signal transduction, exosomes with different biological functions can be secreted by different types of cells. There remains significant uncertainty regarding the clinical transmitter of exosomes to OME, especially in its pathophysiologic development. In this study, the investigators try to elucidate the biological functions of exosomes in children with adenoid hypertrophy accompanied by OME. Patients with adenoid hypertrophy or otitis media will be separated into three groups: those with adenoid hypertrophy, with otitis media and with adenoid hypertrophy and otitis media both, as well as a healthy control group. Participants in the four groups will have their middle ear effusion, nasopharyngeal secretion, and peripheral blood samples taken, from which exosomes will be separated for further analysis. Adenoidectomy will be conducted in adenoid hypertrophy accompanied by OME and adenoid hypertrophy alone and their adenoid tissue will be collected. Blood will be collected again 3 months after surgery and middle ear and nasopharyngeal examinations will be performed. Exosomes will be isolated for follow-up studies as before surgery. Investigators will also use proteome research, exosome biomarkers, and high-throughput sequencing to examine the pathophysiology of OME, particularly inflammation-related etiology, in order to provide novel ideas for OME diagnosis and treatment.

Conditions

Otitis Media With Effusion; Adenoid Hypertrophy

Outcome Measures

Primary Outcomes (3)

• differential gene expression

  ANOVA of the alterations and related gene expression of exosome contents in nasopharyngeal secretions in the four groups

  3 months

• detection of adenoids

  microbial alterations and the exosomes from biofilm on the surface of the adenoids in OA and CA groups preoperative and postoperative

  3 months

• detection of exosomes

  the differences of exosomes from peripheral blood samples in OA and CA groups preoperative and postoperative

  3 months

Study Arms (4)

OA: OME-Adenoid group

Patients who meet the follow inclusion criteria will be considered eligible as the OME-Adenoid (OA) group

Procedure: Adenoidectomy

CA: Control-Adenoid group

Patients who meet the follow inclusion criteria will be considered eligible as the Control-Adenoid (CA) group

Procedure: Adenoidectomy

CO: Control-OME group

Patients who meet the follow inclusion criteria will be considered eligible as the Control-OME (CO) group

control group

Patients without OME and adenoid hypertrophy will be considered eligible as the control group

Interventions

Adenoidectomy PROCEDURE

Adenoidectomy will be conducted in OA and CA groups

CA: Control-Adenoid group; OA: OME-Adenoid group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

240 subjects will be recruited from Eye and ENT hospital of Fudan University or the community.

You may qualify if:

• OME-Adenoid (OA) group:
• Children aged between 4 and 10 years old.
• Diagnosis of chronic otitis media with effusion, and the course of disease is at least 3 months.
• There are varying degrees of hearing loss. PTA (The mean hearing threshold of 500Hz, 1000Hz and 2000Hz) ≥ 30dB.
• Nasopharyngeal lateral X-ray showing A/N \> 0.6 of adenoids.
• Control-Adenoid (CA) group:
• Children aged between 4 and 10 years old.
• Nasopharyngeal lateral X-ray showing A/N \> 0.6 of adenoids.
• Control-OME (CO) group:
• Children aged between 4 and 10 years old.
• Diagnosis of chronic otitis media with effusion, and the course of disease is at least 3 months.
• There are varying degrees of hearing loss. PTA (The mean hearing threshold of 500Hz, 1000Hz and 2000Hz) ≥ 30dB.

You may not qualify if:

• Patients who have had one or more episodes of otitis media in the previous one year.
• Any immunologic diseases.
• Any intrinsic diseases of hearing system, anatomic or physiologic defect of the ear.
• Pharmacologic abnormality.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Adenoidectomy

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 2, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share