A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
Information source: Washington University School of Medicine
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Media With Effusion
Intervention: lansoprazole (Drug)
Phase: N/A
Status: Enrolling by invitation
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
Judith EC Lieu, MD, Principal Investigator, Affiliation: Washington University School of Medicine
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.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Resolution of middle ear fluid by pneumatic otoscopy
Secondary outcome: acoustic reflectometry, tympanometry, reflux symptom questionnaires
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
St. Louis Children's Hospital, St. Louis, Missouri 63110, United States
Additional Information
Related publications: 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.
Starting date: October 2007
Ending date: October 2008
Last updated: October 17, 2007
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