Adenoid HypertrophyNCT04152746
Periostin Levels in Children With Adenoid Hypertrophy
An observational study of Adenoid Hypertrophy and Allergy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluated serum and tissue periostin levels in children with adenoid hypertrophy. Children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy were compared with children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoid Hypertrophy, Allergy, Allergic Rhinitis
- What is being tested?
- Periostin level
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 2 Feb 2020
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consisted of 37 children aged 2-8 years. The study group included 19 children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy due to clinical indications. The control group included 18 children with grade 1 adenoid hypertrophy and no symptoms attributable to adenoid enlargement. All participants had previously documented negative skin prick test results. Children with a history of allergic rhinitis, asthma, immunodeficiency, chronic systemic or endocrine disease, recent upper respiratory tract infection, or prior adenoid surgery were excluded. Serum samples were obtained from all participants, while adenoid tissue and paired normal nasopharyngeal mucosal samples were obtained only from children undergoing adenoidectomy
Who may be able to join
- Children aged 2-8 years. Children with grade 3-4 adenoid hypertrophy scheduled for adenoidectomy due to clinical indications.
- Children with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) and no symptoms attributable to adenoid enlargement for the control group.
- Previously documented negative skin prick test results. Written informed consent obtained from the legal guardians.
Who cannot join
- History of allergic rhinitis. History of asthma. Immunodeficiency. Chronic systemic or endocrine disease. Recent upper respiratory tract infection. Previous adenoid surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
This prospective observational study evaluated serum and tissue periostin levels in children with adenoid hypertrophy. Children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy were compared with children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. Serum periostin levels were compared between the two groups. In the adenoidectomy group, periostin levels in adenoid tissue were also compared with paired samples of normal nasopharyngeal mucosa obtained from the same patients. The study aimed to investigate whether periostin may be associated with the development of adenoid hypertrophy and to explore its potential role in local tissue remodeling.
Read the detailed description
Adenoid hypertrophy (AH) is a common condition in children and may result in nasal obstruction, mouth breathing, sleep-disordered breathing, recurrent upper respiratory symptoms, and other related clinical manifestations. Although allergic inflammation has been proposed as one of the mechanisms contributing to adenoid hypertrophy, the pathophysiological mechanisms underlying tissue enlargement are multifactorial and remain incompletely understood. Periostin is a matricellular protein involved in extracellular matrix organization and tissue remodeling and has been associated with inflammatory and remodeling processes in several airway diseases. However, limited information is available regarding the role of periostin in adenoid hypertrophy.
This prospective observational study was designed to investigate serum and local tissue periostin levels in children with adenoid hypertrophy. The study included children aged 2-8 years who were evaluated for adenoid hypertrophy. The adenoid hypertrophy group consisted of children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy based on their clinical condition. The control group consisted of children with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) who had no symptoms attributable to adenoid enlargement.
Serum periostin levels were measured in both groups and compared between children with grade 3-4 and grade 1 adenoid hypertrophy. In children undergoing adenoidectomy, adenoid tissue samples were obtained during the clinically indicated surgical procedure. Paired samples of normal nasopharyngeal mucosa were also obtained from the posterior pharyngeal wall of the same patients. Periostin concentrations in adenoid tissue and paired normal nasopharyngeal mucosa were measured and compared using a within-subject paired analysis. No tissue samples were obtained from the control group.
The primary objective was to determine whether serum periostin levels differ between children with clinically significant adenoid hypertrophy and children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. A secondary objective was to evaluate whether periostin expression is increased locally in adenoid tissue compared with paired normal nasopharyngeal mucosa in the same patients.
The study was conducted prospectively after obtaining approval from the institutional ethics committee (Approval No. 8/8.11.04.18), and written informed consent was obtained from the legal guardians of all participants. The study was conducted in accordance with the principles of the Declaration of Helsinki.
- Conditions
- Adenoid Hypertrophy, Allergy, Allergic Rhinitis
- Being tested
- Periostin level
- Keywords
- Adenoid Hypertrophy, Periostin
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periostin levelOther
The serum periostin levels were planned to compare between the serum samples that were obtained from the two groups. The evaluation of the periostin levels of adenoid tissue and normal healthy mucosa were also planned.
| Study group | Role | What they receive |
|---|---|---|
| Adenoid Hypertrophy (Grade 3-4) | Children aged 2-8 years with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy based on their clinical condition. Serum periostin levels were measured in this group. Adenoid tissue and paired normal nasopharyngeal mucosa samples were obtained from the same patients during the clinically indicated surgical procedure for tissue periostin analysis. Receives: Other: Periostin level | |
| Control (Grade 1 Adenoid Hypertrophy) | Children aged 2-8 years with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) who had no symptoms attributable to adenoid enlargement. Serum periostin levels were measured for comparison with the adenoid hypertrophy group. No adenoid tissue samples were obtained from participants in this group. Receives: Other: Periostin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum periostin concentration
Serum periostin levels were measured in children with grade 3-4 adenoid hypertrophy and compared with those in children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement.
Measured: At baseline, before adenoidectomy
Secondary outcomes (1)
Periostin concentration in adenoid tissue
Periostin concentration in adenoid tissue was measured in children with grade 3-4 adenoid hypertrophy and compared with periostin concentration in paired normal nasopharyngeal mucosa obtained from the same patients.
Measured: During adenoidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Oct 2019
- Primary completion10 Jan 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid HypertrophyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazan Degirmenci, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152746
- Sponsor's protocol ID
- 8/8.11.04.2018
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2019
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be shared because of participant privacy and confidentiality considerations. Only aggregate study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periostin Levels in Children With Adenoid Hypertrophy
- ClinicalTrials.gov ID
- NCT04152746
- Acronym / sponsor ID
- 8/8.11.04.2018
- Conditions
- Adenoid Hypertrophy, Allergy, Allergic Rhinitis
- Keywords
- Adenoid Hypertrophy, Periostin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 5 Nov 2019 (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.
This prospective observational study evaluated serum and tissue periostin levels in children with adenoid hypertrophy. Children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy were compared with children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. Serum periostin levels were compared between the two groups. In the adenoidectomy group, periostin levels in adenoid tissue were also compared with paired samples of normal nasopharyngeal mucosa obtained from the same patients. The study aimed to investigate whether periostin may be associated with the development of adenoid hypertrophy and to explore its potential role in local tissue remodeling.
Detailed description
Adenoid hypertrophy (AH) is a common condition in children and may result in nasal obstruction, mouth breathing, sleep-disordered breathing, recurrent upper respiratory symptoms, and other related clinical manifestations. Although allergic inflammation has been proposed as one of the mechanisms contributing to adenoid hypertrophy, the pathophysiological mechanisms underlying tissue enlargement are multifactorial and remain incompletely understood. Periostin is a matricellular protein involved in extracellular matrix organization and tissue remodeling and has been associated with inflammatory and remodeling processes in several airway diseases. However, limited information is available regarding the role of periostin in adenoid hypertrophy.
This prospective observational study was designed to investigate serum and local tissue periostin levels in children with adenoid hypertrophy. The study included children aged 2-8 years who were evaluated for adenoid hypertrophy. The adenoid hypertrophy group consisted of children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy based on their clinical condition. The control group consisted of children with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) who had no symptoms attributable to adenoid enlargement.
Serum periostin levels were measured in both groups and compared between children with grade 3-4 and grade 1 adenoid hypertrophy. In children undergoing adenoidectomy, adenoid tissue samples were obtained during the clinically indicated surgical procedure. Paired samples of normal nasopharyngeal mucosa were also obtained from the posterior pharyngeal wall of the same patients. Periostin concentrations in adenoid tissue and paired normal nasopharyngeal mucosa were measured and compared using a within-subject paired analysis. No tissue samples were obtained from the control group.
The primary objective was to determine whether serum periostin levels differ between children with clinically significant adenoid hypertrophy and children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. A secondary objective was to evaluate whether periostin expression is increased locally in adenoid tissue compared with paired normal nasopharyngeal mucosa in the same patients.
The study was conducted prospectively after obtaining approval from the institutional ethics committee (Approval No. 8/8.11.04.18), and written informed consent was obtained from the legal guardians of all participants. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenoid Hypertrophy (Grade 3-4) | – | Other: Periostin levelChildren aged 2-8 years with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy based on their clinical condition. Serum periostin levels were measured in this group. Adenoid tissue and paired normal nasopharyngeal mucosa samples were obtained from the same patients during the clinically indicated surgical procedure for tissue periostin analysis. |
| Control (Grade 1 Adenoid Hypertrophy) | – | Other: Periostin levelChildren aged 2-8 years with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) who had no symptoms attributable to adenoid enlargement. Serum periostin levels were measured for comparison with the adenoid hypertrophy group. No adenoid tissue samples were obtained from participants in this group. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consisted of 37 children aged 2-8 years. The study group included 19 children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy due to clinical indications. The control group included 18 children with grade 1 adenoid hypertrophy and no symptoms attributable to adenoid enlargement. All participants had previously documented negative skin prick test results. Children with a history of allergic rhinitis, asthma, immunodeficiency, chronic systemic or endocrine disease, recent upper respiratory tract infection, or prior adenoid surgery were excluded. Serum samples were obtained from all participants, while adenoid tissue and paired normal nasopharyngeal mucosal samples were obtained only from children undergoing adenoidectomy
Key inclusion criteria (3 listed)
- Children aged 2-8 years. Children with grade 3-4 adenoid hypertrophy scheduled for adenoidectomy due to clinical indications.
- Children with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) and no symptoms attributable to adenoid enlargement for the control group.
- Previously documented negative skin prick test results. Written informed consent obtained from the legal guardians.
Key exclusion criteria (1 listed)
- History of allergic rhinitis. History of asthma. Immunodeficiency. Chronic systemic or endocrine disease. Recent upper respiratory tract infection. Previous adenoid surgery.
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 |
|---|---|---|
| Periostin levelThe serum periostin levels were planned to compare between the serum samples that were obtained from the two groups. The evaluation of the periostin levels of adenoid tissue and normal healthy mucosa were also planned. | Other | Adenoid Hypertrophy (Grade 3-4), Control (Grade 1 Adenoid Hypertrophy) |
Primary outcome
Serum periostin concentration
Time frame: At baseline, before adenoidectomy
Serum periostin levels were measured in children with grade 3-4 adenoid hypertrophy and compared with those in children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement.
1 secondary outcome
Periostin concentration in adenoid tissue
Time frame: During adenoidectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant-level data will not be shared because of participant privacy and confidentiality considerations. Only aggregate study results will be reported.
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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.
Nazan Degirmenci principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoid Hypertrophy and Allergy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum periostin concentration (time frame: At baseline, before adenoidectomy). 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 21 Sep 2026.