A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

This study is being done to see if reflux of stomach fluid might be a cause of fluid in the
ears. Earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the
middle ear fluid of many children with chronic middle ear fluid. Anti-reflux medicines called
proton pump inhibitors (PPI) reduce the acidity of the contents of the stomach and the
activity of pepsin or pepsinogen. We are studying the effectiveness of a PPI called
lansoprazole (Prevacid™) in reducing fluid in the ears. If lansoprazole is able to reduce the
fluid in the middle ear, this tells us that the reflux of gastric acid into the esophagus and
into the ear canal may be causing middle ear fluid.

Inclusion Criteria:

- History of chronic otitis media with effusion meeting clinical indications for
tympanostomy tubes placement, defined as the presence of middle ear fluid on physical
exam for at least 3 months, in at least one ear.

Exclusion Criteria:

- Past medical history or concurrent conditions known to increase the incidence of
either recurrent otitis media or otitis media with effusion or gastroesophageal reflux
disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome,
velocardiofacial syndrome, and primary ciliary dyskinesia.

- Children with structural abnormalities of the tympanic membranes, such as
cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane.
These abnormalities would require placement of tympanostomy tubes in standard clinical
practice.

- Children weighing less than 10 kilograms, due to the lower weight limit for standard
Prevacid™ dosing