This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid
in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole)
will increase the rate of resolution of chronic middle ear fluid in children.
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.
- 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.
- 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
- Children weighing less than 10 kilograms, due to the lower weight limit for standard