Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Exosomes in Otitis Media With Effusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05402267
Recruitment Status : Not yet recruiting
First Posted : June 2, 2022
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
Eye & ENT Hospital of Fudan University

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.


Condition or disease Intervention/treatment
Otitis Media With Effusion Adenoid Hypertrophy Procedure: Adenoidectomy

Detailed Description:

This study will explore the pathogenesis of OME by detecting the exosome in middle ear fluid, nasopharyngeal secretions and peripheral blood in order to identify areas of opportunity for future research and to provide a theoretical basis for drug development for the treatment of secretory otitis media.

240 subjects will be recruited from Eye and ENT hospital of Fudan University or the community. They will be divided into four groups: adenoid hypertrophy accompanied by OME (group OA, n=60), adenoid hypertrophy alone (group CA, n=60), OME alone (group CO, n=60) and healthy control group (children without OME or adenoid hypertrophy, n=60). All participants will undergo the examinations of middle ear and nasopharynx in addition to blood collection when they get into the groups. The exosomes will be isolated form middle ear effusions, nasopharyngeal secretions/adenoid tissue, and peripheral blood collected from all participants. The OA and CA groups will undergo adenoidectomy 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.

The primary outcome measures will be (1) ANOVA of the alterations and related gene expression of exosome contents in nasopharyngeal secretions in the four groups; (2) microbial alterations and the exosomes from biofilm on the surface of the adenoids in OA and CA groups preoperative and postoperative; and (3) the differences of exosomes from peripheral blood samples in OA and CA groups preoperative and postoperative.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Effects of Exosomes in Children With Adenoid Hypertrophy Accompanied by Otitis Media With Effusion
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
OA: OME-Adenoid group
Patients who meet the follow inclusion criteria will be considered eligible as the OME-Adenoid (OA) group
Procedure: Adenoidectomy
Adenoidectomy will be conducted in OA and CA groups

CA: Control-Adenoid group
Patients who meet the follow inclusion criteria will be considered eligible as the Control-Adenoid (CA) group
Procedure: Adenoidectomy
Adenoidectomy will be conducted in OA and CA groups

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



Primary Outcome Measures :
  1. differential gene expression [ Time Frame: 3 months ]
    ANOVA of the alterations and related gene expression of exosome contents in nasopharyngeal secretions in the four groups

  2. detection of adenoids [ Time Frame: 3 months ]
    microbial alterations and the exosomes from biofilm on the surface of the adenoids in OA and CA groups preoperative and postoperative

  3. detection of exosomes [ Time Frame: 3 months ]
    the differences of exosomes from peripheral blood samples in OA and CA groups preoperative and postoperative



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
240 subjects will be recruited from Eye and ENT hospital of Fudan University or the community.
Criteria

Inclusion Criteria:

OME-Adenoid (OA) group:

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

Control-Adenoid (CA) group:

  1. Children aged between 4 and 10 years old.
  2. Nasopharyngeal lateral X-ray showing A/N > 0.6 of adenoids.

Control-OME (CO) group:

  1. Children aged between 4 and 10 years old.
  2. Diagnosis of chronic otitis media with effusion, and the course of disease is at least 3 months.
  3. There are varying degrees of hearing loss. PTA (The mean hearing threshold of 500Hz, 1000Hz and 2000Hz) ≥ 30dB.

Exclusion Criteria:

  1. Patients who have had one or more episodes of otitis media in the previous one year.
  2. Any immunologic diseases.
  3. Any intrinsic diseases of hearing system, anatomic or physiologic defect of the ear.
  4. Pharmacologic abnormality.
Layout table for additonal information
Responsible Party: Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT05402267    
Other Study ID Numbers: OME-2022
First Posted: June 2, 2022    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Otitis
Otitis Media
Otitis Media with Effusion
Hypertrophy
Ear Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical