Periostin Levels in Children With Adenoid Hypertrophy

Periostin is a matricellular protein that has been shown to be a marker of Type 2 inflammation associated with airway eosinophilia. Matricellular proteins are highly expressed at sites of injury or inflammation. Periostin involves tissue fibrosis and remodeling in the nasal mucosa in some of the otolaryngologic diseases. The up-regulation of periostin expression has been shown in allergic rhinitis, chronic rhinosinusitis with nasal polyps , and aspirin intolerant asthma. In the light of these findings the investigators aimed to evaluate the relation between adenoid hypertrophy and periostin levels.

Study Overview

• Status: Completed
• Conditions: Adenoid Hypertrophy
• Intervention / Treatment: Other: Periostin level

Detailed Description

A total of 40 patients-age ranged between 2 and 12 years- were planned to enroll in the study prospectively. Patients that were scheduled to undergo adenoidectomy were included in the study group (adenoid group). The control group comprised of 20 healthy children who had previously been treated for anemia in the out-patient clinic of the Pediatrics Department and were clinically healthy with normal complete blood cell counts at their follow-up visits.

Serum samples were obtained from the two groups. The samples were centrifuged at 1500 g for 5 minute and stored in -80 oC for later analysis of periostin levels. Adenoid tissue and normal mucosal tissue samples were obtained from the adenoidectomy patients and stored in -80 oC for later homogenization and measurement of periostin levels.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients that were scheduled to undergo adenoidectomy were included in the study group (adenoid group). The control group comprised of healthy children who had previously been treated for anemia in the out-patient clinic of the Pediatrics Department and were clinically healthy with normal complete blood cell counts at their follow-up visits.

Description

Inclusion Criteria:

• The patients that were scheduled for adenoidectomy
• Healthy subjects that had not any kind of allergy, adenoid hypertrophy symptoms

Exclusion Criteria(for adenoid group):

• The subjects that had any kind of corticosteroid treatment 1 month prior to surgery, and antihistaminic treatment 2 weeks prior to surgery

Exclusion Criteria(for control group):

• To have allergic rhinitis symptoms
• To have high total IgE levels
• To have positive skin prick test
• To have acute respiratory tract infection
• To have asthma To have any kind of endocrin disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adenoid group; Periostin levels in the adenoid 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.
Control Group; Periostin levels in the control 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

Outcome Measure	Measure Description	Time Frame
Serum Periostin level	Serum periostin levels of the adenoid group and control group will be compared.	1 month
Adenoid tissue Periostin level	Periostin levels of the adenoid tissue and normal mucosal healthy tissue will be compared.	1 month

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Nazan Degirmenci, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): February 2, 2020

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Periostin; Adenoid Hypertrophy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: 8/8.11.04.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No