Food Allergy - Tubes - Adenoids (FATA) Trial

Withdrawn before enrolling · Not applicable

Conditions studied: Otitis Media With Effusion, Food Hypersensitivity

In brief

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.

Key facts

Study ID

NCT00736112

Run by

University of Missouri-Columbia

People needed

0

Starts

2008-10-01

Expected to finish

2015-05-01

Last updated by the study team

2016-09-30

Who can join

Age: any, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Otoscopy reveals Chronic OME.
• Tympanometry confirms fluid in middle ear.
• Children <4 years old
• Lack of improvement after three months of antibiotic therapy.
• History of persistent effusion for three or more months per-episode of OM.
• >3 episodes of AOM in preceding 6 months or >5 episodes of AOM during preceding 12 months
• Bilateral conductive hearing loss of 15 dB or more.

You may not qualify if…

• Previous adenotonsillar surgery or placement of tympanostomy tubes.
• Children with inhalant allergies including asthma.

Where it is running

• University Hospital: Department of Otolaryngology - Head and Neck Surgery — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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