Suppurative Otitis Media Clinical Trial
Official title:
The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis Media in Pediatric Patients in Northern Israel
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.
| Status | Not yet recruiting |
| Enrollment | 240 |
| Est. completion date | February 20, 2020 |
| Est. primary completion date | April 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 9 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Ziv Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | microbiome variability | detection of microbiome differces between suppurative and non-suppurative otitis media in pediatric patients | 2 years |