Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 4

Summary: 
      The accumulation of fluid behind the ear drum without any acute inflammation is known as
      otitis media with effusion (OME). It is the most common cause of acquired hearing loss during
      childhood. Long-term complications of OME include linguistic, developmental, and social
      development delays due to hearing loss.

      The cause of OME is not known; however, low grade infection of the middle ear, poor function
      of the eustachian tube between the ear and the throat, and adenoid hypertrophy have all been
      suggested as possible etiologies. Recent detection of the stomach enzyme pepsin in middle ear
      fluid has led some to propose that OME is related to the reflux of stomach contents into the
      ear, via the eustachian tube.

      The purpose of the investigators study is to determine whether anti-reflux medication may
      have a positive impact by clearing the accumulation of fluid in the middle ear with the aim
      of preventing or reducing hearing loss in children diagnosed with OME. Empiric anti-reflux
      therapy with proton pump inhibitor (PPI) medication is safe, proven and cost-effective. It is
      used widely as a diagnostic and treatment strategy in the presence of the signs and symptoms
      of gastroesophageal reflux disease (GERD). The signs and symptoms of GERD include heartburn,
      recurrent vomiting or regurgitation, acid taste in mouth, throat irritation, voice problems,
      heartburn, difficult or painful swallowing, asthma and recurrent pneumonia.

      This pilot study will be a double-blinded, randomized, placebo-controlled trial that will
      compare resolution rates for OME in children treated with lansoprazole or placebo for three
      months. At the end of the study, those patients who have persistent middle ear effusions will
      be brought to the operating room and have the fluid aspirated and sent for analysis for
      pepsin.
    

Detailed description: 
      Otitis media with effusion (OME) is a condition characterized by the accumulation of
      non-purulent fluid in the middle ear space, in the absence of acute inflammation. OME is
      diagnosed 2.2 million times annually (U.S. Department of Health & Human Services, 2000). It
      is a condition in which more then 50% of children will experience in their first year of life
      (National Institutes of Health, 1993). Although many episodes resolve spontaneously, 30% to
      40% persist, and 5% to 10% of episodes last 1 year or longer (Yoshinaga-Itano, 1995). It is
      particularly more common among children between the ages of one and three years and in
      seasons where the prevalence of upper respiratory tract infections is high; with an incidence
      of 10% to 30%. It occurs frequently even up to the age of seven, with a prevalence of 3% to
      8%(Fiellau et al, 1997; Fiellau et al, 1983; Lous et al, 1981; Teele et al, 1989).

      OME is the most common cause of acquired hearing loss in childhood. Long-term hearing
      complications from OME are associated with linguistic, developmental, and social
      consequences; especially if the OME is bilateral and of long duration (Fiellau et al, 1983;
      Golz et al, 1998; Grace et al, 1990; Lous et al, 1995). The etiology of OME is uncertain;
      however, low-grade infection, poor eustachian tube function, formation of biofilms, and
      adenoidal infection or hypertrophy have all been suggested as possible etiologies (Faden et
      al, 1998; Hall-Stoodley et al, 2006).

      Recently, there has been good scientific evidence to suggest that OME is a supraesophageal
      manifestation of gastroesophageal reflux disease (GERD), and more specifically
      laryngo-pharyngeal reflux (LPR). Tasker et al (2002) investigated the potential role of
      gastric reflux in the development of OME in children who underwent myringotomy. Of 65 tested
      effusion samples, 59 (91%) effusions gave a positive result. The concentrations of
      pepsin/pepsinogen were roughly estimated to be about 1000 times higher than those found in
      the serum obtained from a number of controls. They speculated that pepsin found in middle ear
      effusion (MEE) was most probably due to micro-aspiration of gastric contents passing through
      the eustachian tube (ET) and reaching the middle ear. Lieu et al (2005) performed a pilot
      study where they replicated the finding of pepsin/pepsinogen in 17 of 36 (77%) middle ear
      fluid aspirates, obtained from 22 children who underwent tympanostomy tube placement for
      chronic or recurrent otitis media (OM).

      Based on our literature review, we believe there is sufficient scientific evidence to support
      the empiric treatment of suspected GERD and LPR in patients with OME. Empiric anti-reflux
      therapy is a safe, proven, cost-effective diagnostic and treatment strategy used widely in
      the presence of other signs and symptoms of suspected GERD. This pilot study will be a
      double-blinded, randomized control trial. It will compare hearing outcomes for children with
      OME being treated with lansoprazole versus placebo for three months. We believe there is
      sufficient evidence to support the use of this strategy in patients with suspected GERD and
      LPR who present with OME.
    

Intervention name(s): Lansoprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dosage of Lansoprazole will be administered based on guidelines set out by the prescription drug information outlined in the official Lansoprazole package insert and will remain the same for each patient during the 3 month period and is as follows: a) 1 to 11 years of age, weight less then or equal to 30 kg, 15 mg orally once daily. b) 1 to 11 years of age, weight greater then 30 kg, 30 mg orally once daily. c) 12 years of age and older, 15 mg orally once daily. The doses of Lansoprazole will be prepared in liquid form by the Inpatient Pharmacy at Hamilton Health Sciences.; Lactose powder in 8.4% Sodium Bicarbonate (Liquid placebo)
Other intervention name(s): Prevacid
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment