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Completed

NCT Number: NCT04152746

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.

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Key information

Conditions

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periostin level

Other

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.

Primary outcomes

  1. Serum Periostin level

    Time frame: 1 month

    Serum periostin levels of the adenoid group and control group will be compared.

  2. Adenoid tissue Periostin level

    Time frame: 1 month

    Periostin levels of the adenoid tissue and normal mucosal healthy tissue will be compared.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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