Food Hypersensitivity Clinical Trial
— FATAOfficial title:
A New Approach to Otitis Media With Effusion (OME)
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 4 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Hospital: Department of Otolaryngology - Head and Neck Surgery | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Trial participants will have follow-up appointments every three months until tubes fall out, then patients will have F/U every three months for one year for evaluation of recurrent middle ear fluid. | No |
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