Ignite Creation Date:
2024-05-05 @ 10:21 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01082029
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2010-03-04
Brief Title:
Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Role of Empiric Anti-reflux Therapy in Pediatric Otitis Media With Effusion - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 22 million times annually US 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 8Fiellau 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 pepsinpepsinogen 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 pepsinpepsinogen 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
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 pepsinpepsinogen 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 pepsinpepsinogen 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None