Otitis Media With EffusionNCT05402267
The Effects of Exosomes in Otitis Media With Effusion
An observational study of Otitis Media With Effusion and Adenoid Hypertrophy, run by Eye & ENT Hospital of Fudan University.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media With Effusion, Adenoid Hypertrophy
- What is being tested?
- Adenoidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 240 subjects will be recruited from Eye and ENT hospital of Fudan University or the community.
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Otitis Media With Effusion, Adenoid Hypertrophy
- Being tested
- Adenoidectomy
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenoidectomyProcedure or surgery
Adenoidectomy will be conducted in OA and CA groups
| Study group | Role | What they receive |
|---|---|---|
| OA: OME-Adenoid group | Patients who meet the follow inclusion criteria will be considered eligible as the OME-Adenoid (OA) group Receives: Procedure: Adenoidectomy | |
| CA: Control-Adenoid group | Patients who meet the follow inclusion criteria will be considered eligible as the Control-Adenoid (CA) group Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
differential gene expression
ANOVA of the alterations and related gene expression of exosome contents in nasopharyngeal secretions in the four groups
Measured: 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
Measured: 3 months
detection of exosomes
the differences of exosomes from peripheral blood samples in OA and CA groups preoperative and postoperative
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402267
- Sponsor's protocol ID
- OME-2022
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exosomes in Children With Adenoid Hypertrophy Accompanied by Otitis Media With Effusion
- ClinicalTrials.gov ID
- NCT05402267
- Acronym / sponsor ID
- OME-2022
- Conditions
- Otitis Media With Effusion, Adenoid Hypertrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OA: OME-Adenoid group | – | Procedure: AdenoidectomyPatients who meet the follow inclusion criteria will be considered eligible as the OME-Adenoid (OA) group |
| CA: Control-Adenoid group | – | Procedure: AdenoidectomyPatients who meet the follow inclusion criteria will be considered eligible as the Control-Adenoid (CA) group |
| 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 |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 240 subjects will be recruited from Eye and ENT hospital of Fudan University or the community.
Key inclusion criteria (12 listed)
- 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.
- Children aged between 4 and 10 years old.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenoidectomyAdenoidectomy will be conducted in OA and CA groups | Procedure or surgery | CA: Control-Adenoid group, OA: OME-Adenoid group |
Primary outcome
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
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
detection of exosomes
Time frame: 3 months
the differences of exosomes from peripheral blood samples in OA and CA groups preoperative and postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media With Effusion and Adenoid Hypertrophy, run by Eye & ENT Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differential gene expression (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.