Status unknownNCT03456739Updated Mar 7, 2018

The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis

An observational study in Suppurative Otitis Media, sponsored by Ziv Hospital. Status unknown. Open to participants aged 1 Year to 9 Years. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Ziv Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.

Study type: Observational
Model: Ecologic or community
Time perspective: Prospective
Enrollment: 240
Ages: 1 Year to 9 Years
Sex: All

Study 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.

Conditions studied

Suppurative Otitis Media

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Who can participate

Ages eligible: 1 Year to 9 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

pediatric patients with suppurative otitis media with effusion

Eligibility 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.

Study design

Observational model: Ecologic or community
Time perspective: Prospective
Enrollment: 240 participants (estimated)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

suppurative otitis media with effusion
non suppurative otitis media with effusion

What researchers measure

Primary outcomes

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

Study locations

No study locations are listed for this record.

Registry details

Key details

Study ID: NCT03456739
Lead sponsor: Ziv Hospital
Responsible party: Sponsor
First posted: Mar 7, 2018
Start date: Apr 20, 2018 (estimated)
Primary completion: Apr 20, 2019 (estimated)
Completion: Feb 20, 2020 (estimated)
Last update: Mar 7, 2018

Study contacts

saqer massuod, md

Contact

saqr.m@ziv.health.gov.il

972-4-6828470

saqer massuod, MD

principal investigator · Ziv Medical Center

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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