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Otitis Media With Effusion | Food Allergy - Tubes - Adenoids (FATA) Trial

Otitis Media With Effusion research study

What is the primary objective of this study?

The questioned proposed by this study is one of treatment: \"To what extent does simultaneous BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and diagnosis/avoidance of food allergy affect the frequency of recurrent otitis media (ROM) versus the standard academy approach (tube insertions only) to chronic otitis media with effusion; furthermore, are adenoids a factor in OME or is food allergy diagnosis and treatment able to significantly prevent ROM after the tubes fall out?\" The trial seeks to provide evidence that the treatment for Chronic OME in children should involve surgical procedures (BMT +/- adenoidectomy), as well, as a food allergy work-up and subsequent avoidance of the offending foods in order to significantly decrease ROM. To answer this question, a prospective, randomized controlled trial needs to be conducted. Since a majority of OME patients are from the pediatric population, parental consent must be obtained. Subjects in our study will initially present to the clinic with otitis media symptoms and diagnostic tests such as a tympanogram, otoscopy, and history of recurrent otitis media will be obtained. Once the surgical decision for bilateral myringotomy and tympanostomy tubes has been made, parents will be informed about the trial. The standard protocol for children presenting with initial Chronic OME is to perform a BMT. Therefore, data from the control group (Group 1) will be obtained from faculty ENT who follow the academy's recommendations. Data from Group 2 and 3 will be collected from other ENT faculty members, including the faculty co-investigator who will perform the BMT and obtain a food allergy blood draw at the time of surgery. The study's faculty co-investigator will describe food avoidance techniques to post-op patients from Groups 2 and 3. Patients with previous adenotonsillar surgery or placement of tympanostomy tubes will not be enrolled in the study. The incidence of ROM episodes in all trial groups will be recorded.

Who is eligible to participate?

Inclusion Criteria: 1. Otoscopy reveals Chronic OME. 2. Tympanometry confirms fluid in middle ear. 3. Children <4 years old 4. Lack of improvement after three months of antibiotic therapy. 5. History of persistent effusion for three or more months per-episode of OM. 6. >3 episodes of AOM in preceding 6 months or >5 episodes of AOM during preceding 12 months 7. Bilateral conductive hearing loss of 15 dB or more. Exclusion Criteria: 1. Previous adenotonsillar surgery or placement of tympanostomy tubes. 2. Children with inhalant allergies including asthma.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Otitis Media With Effusion

Food Hypersensitivity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Food Allergy TestingFood Allergy Diagnosis - blood drawn for food allergy testing at the time of surgery (bilateral myringotomy with tympanostomy tubes +/- adenoidectomy)

Procedure:AdenoidectomyAdenoidectomy to remove adenoid tissue. (Are adenoids a factor in OME (otitis media with effusion) or is food allergy diagnosis and treatment able to significantly prevent ROM (recurrent otitis media) after the tubes fall out?)

Procedure:BMTThe standard protocol for children presenting with initial Chronic OME is to perform a BMT

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

BMT and food allergytrial subjects will receive food allergy testing and management in conjunction with BMT (Bilateral Myringotomy with Tympanostomy Tubes). Food allergy management involves parental education on how to avoid the specific offending foods.

BMT and adenoidectomyinvolves BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and food allergy testing and management. Food allergy management involves parental education on how to avoid the specific offending foods.

BMT aloneThe standard protocol for children presenting with initial Chronic OME is to perform a BMT (Bilateral Myringotomy with Tympanostomy Tubes).

Study Status

Withdrawn

Start Date: October 2008

Completed Date: May 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The number of post-op ROM episodes in each group (1,2,3) will be recorded throughout the study (after the tympanostomy tubes fall out).

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Young Paik, MD

Lead Sponsor: University of Missouri-Columbia

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00736112

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