The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis Media in Pediatric Patients in Northern Israel
| Registry | NCT03456739 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 240 (Estimated) |
| Sponsor | Ziv Hospital (Other gov) |
| Conditions | Suppurative Otitis Media |
| Dates | start 2018-04-20 (estimated), primary completion 2019-04-20 (estimated), completion 2020-02-20 (estimated), first posted 2018-03-07, last updated 2018-03-07 |
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All trials for Suppurative Otitis Media
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| suppurative otitis media with effusion | |||
| non suppurative otitis media with effusion |
Sex: All, ages: 1 Year to 9 Years
Inclusion otitis media with effusion,parental informed consent, age between 1 - 9 years, no known immune deficient disorder - Exclusion Criteria:no parental consent, known immune disorder, current acute otitis media. \-