Clinical trial NCT04152746: Periostin Levels in Children With Adenoid Hypertrophy
Official title: Periostin Levels in Children With Adenoid Hypertrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoid Hypertrophy
Keywords: Adenoid Hypertrophy
Periostin
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Periostin level
timeFrame: 1 month
measure: Adenoid tissue Periostin level
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Nazan Degirmenci
role: PRINCIPAL_INVESTIGATOR
References: