Periostin Levels in Children With Adenoid Hypertrophy

Adenoid Hypertrophy Clinical Trial

Official title:

Periostin Levels in Children With Adenoid Hypertrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152746
• Other study ID #: 8/8.11.04.2018
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: February 2, 2020

Study information

• Verified date: March 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoid Hypertrophy
• Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Periostin level	Serum periostin levels of the adenoid group and control group will be compared.	1 month
Primary	Adenoid tissue Periostin level	Periostin levels of the adenoid tissue and normal mucosal healthy tissue will be compared.	1 month