Otitis Media With Effusion Clinical Trial
Official title:
The Effects of Exosomes in Children With Adenoid Hypertrophy Accompanied by Otitis Media With Effusion
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03590912 -
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion
|
Phase 4 | |
Completed |
NCT03611842 -
Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
|
||
Not yet recruiting |
NCT01421199 -
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
|
N/A | |
Completed |
NCT01202578 -
Evaluation of the Tympanostomy Tube Delivery System
|
Phase 2/Phase 3 | |
Completed |
NCT00629694 -
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
|
Phase 2 | |
Completed |
NCT00520039 -
Osteopathic Otitis Media Research Study
|
N/A | |
Completed |
NCT00195611 -
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
|
Phase 4 | |
Not yet recruiting |
NCT04584073 -
Secretory Otitis Media in Adenoids Hypertrophy Patients
|
N/A | |
Withdrawn |
NCT00736112 -
Food Allergy - Tubes - Adenoids (FATA) Trial
|
N/A | |
Completed |
NCT00546117 -
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
|
N/A | |
Withdrawn |
NCT02950311 -
Xylitol for Otitis Media
|
Phase 2/Phase 3 | |
Recruiting |
NCT05324696 -
Autoinflation: Alternative in the Treatment of Otitis Media With Effusion
|
N/A | |
Recruiting |
NCT05353569 -
Coherent Optical Detection of Middle Ear Disease
|
N/A | |
Completed |
NCT02282540 -
Novel Imaging of the Eustachian Tube; Patient Study
|
N/A | |
Not yet recruiting |
NCT03491098 -
The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
|
Early Phase 1 | |
Completed |
NCT01082029 -
Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
|
Phase 4 | |
Completed |
NCT00939796 -
Clinical Study of the Tympanostomy Tube Delivery System
|
N/A | |
Recruiting |
NCT06316635 -
Microplastics in Otitis Media With Effusion Material
|
||
Recruiting |
NCT02215681 -
Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
|
N/A | |
Completed |
NCT02183974 -
Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion
|
N/A |