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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Washington University School of Medicine

Current Primary Outcome:

  • Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear [ Time Frame: 2 months ]
  • Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar [ Time Frame: 2 months ]


Original Primary Outcome: Resolution of middle ear fluid by pneumatic otoscopy [ Time Frame: 2 months ]

Current Secondary Outcome:

  • Acoustic Reflectometry [ Time Frame: 2 months ]
  • Tympanometry [ Time Frame: 2 months ]
  • Reflux Symptom Questionnaires [ Time Frame: 1 and 2 months ]


Original Secondary Outcome: acoustic reflectometry, tympanometry, reflux symptom questionnaires [ Time Frame: 2 months ]

Information By: Washington University School of Medicine

Dates:
Date Received: October 17, 2007
Date Started: October 2007
Date Completion:
Last Updated: September 27, 2011
Last Verified: September 2011