Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
The accumulation of fluid behind the ear drum without any acute inflammation is known as
otitis media with effusion (OME). It is the most common cause of acquired hearing loss during
childhood. Long-term complications of OME include linguistic, developmental, and social
development delays due to hearing loss.
The cause of OME is not known; however, low grade infection of the middle ear, poor function
of the eustachian tube between the ear and the throat, and adenoid hypertrophy have all been
suggested as possible etiologies. Recent detection of the stomach enzyme pepsin in middle ear
fluid has led some to propose that OME is related to the reflux of stomach contents into the
ear, via the eustachian tube.
The purpose of the investigators study is to determine whether anti-reflux medication may
have a positive impact by clearing the accumulation of fluid in the middle ear with the aim
of preventing or reducing hearing loss in children diagnosed with OME. Empiric anti-reflux
therapy with proton pump inhibitor (PPI) medication is safe, proven and cost-effective. It is
used widely as a diagnostic and treatment strategy in the presence of the signs and symptoms
of gastroesophageal reflux disease (GERD). The signs and symptoms of GERD include heartburn,
recurrent vomiting or regurgitation, acid taste in mouth, throat irritation, voice problems,
heartburn, difficult or painful swallowing, asthma and recurrent pneumonia.
This pilot study will be a double-blinded, randomized, placebo-controlled trial that will
compare resolution rates for OME in children treated with lansoprazole or placebo for three
months. At the end of the study, those patients who have persistent middle ear effusions will
be brought to the operating room and have the fluid aspirated and sent for analysis for
pepsin.