Study Stopped
The investigator left the institution
Food Allergy - Tubes - Adenoids (FATA) Trial
FATA
A New Approach to Otitis Media With Effusion (OME)
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedSeptember 30, 2016
September 1, 2016
6.6 years
August 14, 2008
September 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
BMT and food allergy
EXPERIMENTALtrial 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 adenoidectomy
EXPERIMENTALinvolves 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 alone
ACTIVE COMPARATORThe standard protocol for children presenting with initial Chronic OME is to perform a BMT (Bilateral Myringotomy with Tympanostomy Tubes).
Interventions
Food Allergy Diagnosis - blood drawn for food allergy testing at the time of surgery (bilateral myringotomy with tympanostomy tubes +/- 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?)
The standard protocol for children presenting with initial Chronic OME is to perform a BMT
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital: Department of Otolaryngology - Head and Neck Surgery
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Paik, MD
University of Missouri-Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 15, 2008
Study Start
October 1, 2008
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 30, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share