Periostin Levels in Children With Adenoid Hypertrophy

Completed

• Conditions: Adenoid Hypertrophy
• Interventions: Other: Periostin level

• Registration Number: NCT04152746
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

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 Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Primary Completion: 2020-01-10
• Study Completion: 2020-02-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Periostin level	Periostin levels in the control group
Adenoid group	Periostin level	Periostin levels in the adenoid group

Primary Outcome Measures

Name	Time	Method
Adenoid tissue Periostin level	1 month	Periostin levels of the adenoid tissue and normal mucosal healthy tissue will be compared.
Serum Periostin level	1 month	Serum periostin levels of the adenoid group and control group will be compared.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey