The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis

The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis Media in Pediatric Patients in Northern Israel

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03456739

Enrollment

240

Registered

2018-03-07

Start date

2018-04-20

Completion date

2020-02-20

Last updated

2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suppurative Otitis Media

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 9 Years

Healthy volunteers

Inclusion criteria

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. \-

Design outcomes

Primary

Measure	Time frame	Description
microbiome variability	2 years	detection of microbiome differces between suppurative and non-suppurative otitis media in pediatric patients

Contacts

Primary Contactsaqer massuod, md

saqr.m@ziv.health.gov.il972-4-6828470

Outcome results