The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis

• Conditions: Suppurative Otitis Media

• Registration Number: NCT03456739
• Lead Sponsor: Ziv Hospital

Brief Summary

ear swabs will be collected from 120 patients with established CSOM at the ear-nose-throat (ENT) outpatient clinic at the Ziv medical center, and 120 swabs will be taken from children with Otitis Media with Effusion (OME) undergoing elective tympanostomy tube insertion, serving as a control group. Ear swabs will be frozen at -80C until analysis.DNA will be purified from ear swabs, and amplified by PCR so that a barcoded 16S rRNA library from each subject will be generated. Using correlation analysis, we will compare between microbial compositions in chronic otorrhea patients vs. control groups.An additional ear swab will be collected from patients and cultured to test antibiotic resistance.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-02-28
• Last Update Submitted: 2018-02-28
• Study First Posted: 2018-03-07
• Last Update Posted: 2018-03-07
• Study Start: 2018-04-20
• Primary Completion: 2019-04-20
• Study Completion: 2020-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

no parental consent, known immune disorder, current acute otitis media.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
microbiome variability	2 years	detection of microbiome differces between suppurative and non-suppurative otitis media in pediatric patients