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.

• Experimental: Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
• Placebo Comparator: Placebo SoluTab once daily for 2 months

• Lieu JE, Muthappan PG, Uppaluri R. Association of reflux with otitis media in children. Otolaryngol Head Neck Surg. 2005 Sep;133(3):357-61.
• Tasker A, Dettmar PW, Panetti M, Koufman JA, P Birchall J, Pearson JP. Is gastric reflux a cause of otitis media with effusion in children? Laryngoscope. 2002 Nov;112(11):1930-4.
• Abd El-Fattah AM, Abdul Maksoud GA, Ramadan AS, Abdalla AF, Abdel Aziz MM. Pepsin assay: a marker for reflux in pediatric glue ear. Otolaryngol Head Neck Surg. 2007 Mar;136(3):464-70.
• Sone M, Yamamuro Y, Hayashi H, Yanagi E, Niwa Y, Nakashima T. Prediction of gastroesophageal reflux in otitis media with effusion in adults. Acta Otolaryngol. 2007 May;127(5):470-3.

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

• Doris Duke Charitable Foundation
• TAP Pharmaceutical Products Inc.