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RecruitingNCT06316635Updated Mar 27, 2024

Microplastics in Otitis Media With Effusion Material

An observational study in Microplastics, Otitis Media With Effusion and Biofilms, sponsored by Kerem Kökoğlu. Recruiting at 1 site in Turkey. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Kerem Kökoğlu · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Ages
Up to 18 Years
Sex
All
01

Study summary

Microplastic rate is increasing ib athmosphere. They can be found in lung, kidney, heart, even placenta. Otitis media with effusion (OME) is a clinical condition that is ver common in children. Biofilms are blamed in the pathogenesis of OME. Microplastics can include biofilms. Importance of microplastics for potential pathogens and their toxicity aspects should be enlighted with studies. This study aims to investigate presency of microplastics in middle ear fluid of patients with OME.

Read the detailed description

This study was planned prospectively. With ethical approvel, patients who were followed by bilateral OME at least for three months or one-sided OME at least for 9 months were enrolled to the study. Patients with craniofacial anomaly, cleft palate, had history of previous ear surgery were excluded. They were operated as paracentesis and ventilation tube implementation (VTI). An informed consent form was obtained from them and their parents.

Operation: Surgical indication was made according to disease duration and/or hearing loss. Patients were operated under general anesthesia. Paracentesis was made from posteroinferior quadrant of tympanic membrane. Glu material was trapped in the suction tube and tranferred to glass tubes immediately (Figure 1). For this, glass syringe and 0.9 % serum physiologic were used. Samples were sent from right and left ear seperately. Microplastics determination was made in Enviromental Engineering Labaratory of Faculty of Engineering.

Microplastics Determination Method: It applied according to Prada et. al report (11). Fragments, except blood clots, were washed with a jet of filtered distilled water inside the laminar flow hood to remove any surface contamination and all samples were weighed inside closed glass flasks to the nearest 0.1 mg (Sartorius, Entris, Germany). A method for preparing biological samples for Nile Red staining, previously developed and tested, was followed [16]: (i) incubation for 24 h at 60 °C (Oasis™ Benchtop IR CO2 Incubator, Caron, OH, USA) in 30 mL of 10% KOH (w/v, ≥85%, Labchem, PA, USA); (ii) at 24 h, the temperature was raised to boiling point and the solution immediately filtered on glass fiber filter membrane (1.2 µm pore, Whatman® GF/C, Little Chalfont, Buckinghamshire, UK) mounted in a vacuum glass filtration system; (iii) 100 mL of boiling filtered distilled water was filtered to remove soaps; (iv) 10 mL of acetone was added to the cup for 10 min; (v) an additional 10 mL of acetone was filtered to remove lipophilic matter; (vi) 0.5-1 mL of 0.01 mg mL-1 of Nile Red (microscopy grade, Sigma-Aldrich, St. Louis, MO, USA) was added to the cup for 5 min; (vii) 50 mL of distilled water was filtered; and (viii) stored in glass Petri dishes kept inside cardboard boxes for a week to dry at room temperature (20 °C).

Contamination Control Measures Strict contamination control measures were conducted in all phases, namely by: (i) wearing cotton lab coats and clean gloves; (ii) working in the laminar flow hood in a clean room, maintained by cleaning with ethanol in paper towels followed by cleaning with a duster that attracts and traps dust particles and paper fibers; (iii) filtering all solutions (1.2 µm pore, Whatman® GF/C); (iv) using glass and metal materials; (v) decontaminating glass materials by submerging them in 10% HNO3 for at least 30 min and rinsing with distilled water; (vi) additionally cleaning glass Petri dishes with a N2 air jet; (vii) burning glass microfiber filter membranes at 450 °C for 3 h; (viii) cleaning the cup of the filtration system between samples by dipping it for 15 s in a solution (first batch: acetone, second batch: 30% HNO3) followed by dipping in distilled water; (ix) keeping sample containers closed as much as possible with glass lids, caps, or aluminum foil; and (x) conducting procedural blanks (solutions without samples exposed to sample preparation procedures) for each batch. Each samples were tested by three times for verification. In addition, microplastics were evaluated in serum psyisologic to prevent contamination.

02

Conditions studied

  • Microplastics
  • Otitis Media With Effusion
  • Biofilms

Keywords

  • microplastics
  • hearing loss
  • otitis media
  • biofilm
  • air pollution
03

In context

Otitis Media with Effusion

88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.

This study's planned enrollment of 40 is below the median of 150 across 21 observational studies indexed under Otitis Media with Effusion.

Browse Otitis Media with Effusion studies →

Lead sponsor

This is the only study on the registry with Kerem Kökoğlu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Any age, patients with bilateral OME at least 3 months or unilateral OME at least 9 months

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who were followed by bilateral OME at least for three months or one-sided OME at least for 9 months were enrolled to the study

Exclusion criteria

Exclusion Criteria:

  • Patients with craniofacial anomaly, cleft palate, had history of previous ear surgery were excluded
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
40 Days
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • patient group

    patient group has formed as operated patients because of OME A paracentesis and ventilation tube insertion will be performed them. After paracentesis, effusion otitis media will be trapped and sampled for microplastic analysis.

    Procedure: ventilation tube insertion

Interventions

  • Procedureventilation tube insertion

    a paracentesis will be done to tympanic membrane. Glu will be aspirated and trapped.

06

What researchers measure

Primary outcomes

  1. Microplastic presence

    They will be commented as yes / no. Microplastics Determination Method: It applied according to Prada et. al report. Fragments, except blood clots, were washed with a jet of filtered distilled water inside the laminar flow hood to remove any surface contamination and all samples were weighed inside closed glass flasks to the nearest 0.1 mg (Sartorius, Entris, Germany). A method for preparing biological samples for Nile Red staining, previously developed and tested, was followed.

    Time frame: from March 2024 to April 2024

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2024 (actual). Primary completion is estimated for Apr 2024, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2024
First posted
Mar 18, 2024
StartActual
Mar 20, 2024
Primary completionEst.
Apr 20, 2024
CompletionEst.
Apr 20, 2024
Last update
Mar 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06316635
Lead sponsor
Kerem Kökoğlu
Responsible party
Kerem Kökoğlu (Principal Investigator, TC Erciyes University) — Sponsor-investigator
First posted
Mar 18, 2024
Start date
Mar 20, 2024
Primary completion
Apr 20, 2024 (estimated)
Completion
Apr 20, 2024 (estimated)
Last update
Mar 27, 2024

Study contacts

KEREM KÖKOĞLU, Assoc Prof.
Contact
dr.kokoglu@gmail.com
+905352056780
Mehmet I Şahin, Assoc Prof.
principal investigator · TC Erciyes University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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