Conditions: Otitis Media With Effusion
Keywords: otitis media with effusion gastroesophageal reflux ear infection proton pump inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months arm 2: Placebo SoluTab once daily for 2 months

Interventions: intervention 1: lansoprazole intervention 2: placebo
Intervention descriptions: intervention 1: Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing \>30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm. intervention 2: Placebo Solutab in 15 and 30 mg dosages.

Protocol document: