Food Allergy - Tubes - Adenoids (FATA) Trial

Summary

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.

Conditions

• Otitis Media With Effusion
• Food Hypersensitivity

Interventions

OTHER

Food Allergy Testing

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

PROCEDURE

Adenoidectomy

Adenoidectomy 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

BMT

The standard protocol for children presenting with initial Chronic OME is to perform a BMT

Sponsors & Collaborators

• University of Missouri-Columbia

  lead OTHER

Principal Investigators

• Young Paik, MD · University of Missouri-Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

4 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2015-05-31

Completion

2015-05-31

Countries

• United States

Study Locations