Periostin Levels in Children With Adenoid Hypertrophy

September 16, 2026 updated by: Bezmialem Vakif University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

History of allergic rhinitis. History of asthma. Immunodeficiency. Chronic systemic or endocrine disease. Recent upper respiratory tract infection. Previous adenoid surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CONTROL
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Periostin level

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.
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.
Other: Periostin level

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline, before adenoidectomy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Periostin concentration in adenoid tissue
Time Frame: During adenoidectomy

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.
During adenoidectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nazan Degirmenci, Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8/8.11.04.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant-level data will not be shared because of participant privacy and confidentiality considerations. Only aggregate study results will be reported.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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