Food Allergy - Tubes - Adenoids (FATA) Trial
| Status: | Completed |
|---|---|
| Conditions: | Food Studies, Other Indications, Infectious Disease, Neurology |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology, Pharmacology / Toxicology, Other |
| Healthy: | No |
| Age Range: | Any - 4 |
| Updated: | 7/11/2015 |
| Start Date: | October 2008 |
| End Date: | October 2010 |
| Contact: | Young Paik, M.D. |
| Email: | PaikY@health.missouri.edu |
| Phone: | (573) 882-8173 |
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.
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.
Design: Randomized controlled trial to evaluate the efficacy of a new approach in the
treatment of children presenting with chronic otitis media with effusion. The new approach
calls for a surgical correction of OME by a BMT (Bilateral Myringotomy with Tympanostomy
Tubes) +/- Adenoidectomy, with additional food allergy diagnosis and subsequent management
of offending foods in order to reduce the frequency of recurrent otitis media (ROM).
End Points: Comparison between groups (1,2,3) on the recurrence of otitis media following
surgery. All trial participants will have follow-up clinic appointments every three months
until tubes fall out and after this point, patients will present to clinic every three
months for one year for evaluation of recurrent middle ear fluid. Questionnaires will be
administered to Groups 2 & 3 at the F/U appointments to evaluate food allergy management.
Methodology: Trial participants will be identified by their otitis media signs and
symptoms. Subjects who meet the inclusion criteria will be asked to participate in the
study and consent will be obtained. Surgery will be performed based on group assignment.
All trial subjects will receive standard post-op care and will also be seen for clinical
evaluation q 3 months post-surgery, and then q 3 months after the tubes are out for one
year. The number of otitis media episodes during the follow up year in children assigned to
groups 1,2, and 3 will be recorded.
Procedures: At the initial clinic visit, potential trial subjects will be asked about their
otitis media history, including how many episodes of OM in the past six months, evidence of
hearing loss, lack of response to antibiotic therapy, prolonged periods of OME, and previous
tympanograms. Pediatric patients will have their tympanic membranes (TM) evaluated by
otoscopy for evidence of OME. Tympanometry will also be performed to confirm the presence
of fluid in the middle ear.
Participants in the control group (Group 1) will receive the standard academy regimen for
initial presentation of Chronic OME, which is insertion of BMT. Group 2 trial subjects will
receive food allergy testing and management in conjunction with BMT. Group 3 involves BMT
insertion, adenoidectomy, and food allergy testing and management.
Food management involves parental education on how to avoid the specific offending foods by
their allergic children.
The total length of subject participation is variable depending on when the tubes come out.
Once the tubes have fallen out, the patient will be evaluated every three months for one
full year.
treatment of children presenting with chronic otitis media with effusion. The new approach
calls for a surgical correction of OME by a BMT (Bilateral Myringotomy with Tympanostomy
Tubes) +/- Adenoidectomy, with additional food allergy diagnosis and subsequent management
of offending foods in order to reduce the frequency of recurrent otitis media (ROM).
End Points: Comparison between groups (1,2,3) on the recurrence of otitis media following
surgery. All trial participants will have follow-up clinic appointments every three months
until tubes fall out and after this point, patients will present to clinic every three
months for one year for evaluation of recurrent middle ear fluid. Questionnaires will be
administered to Groups 2 & 3 at the F/U appointments to evaluate food allergy management.
Methodology: Trial participants will be identified by their otitis media signs and
symptoms. Subjects who meet the inclusion criteria will be asked to participate in the
study and consent will be obtained. Surgery will be performed based on group assignment.
All trial subjects will receive standard post-op care and will also be seen for clinical
evaluation q 3 months post-surgery, and then q 3 months after the tubes are out for one
year. The number of otitis media episodes during the follow up year in children assigned to
groups 1,2, and 3 will be recorded.
Procedures: At the initial clinic visit, potential trial subjects will be asked about their
otitis media history, including how many episodes of OM in the past six months, evidence of
hearing loss, lack of response to antibiotic therapy, prolonged periods of OME, and previous
tympanograms. Pediatric patients will have their tympanic membranes (TM) evaluated by
otoscopy for evidence of OME. Tympanometry will also be performed to confirm the presence
of fluid in the middle ear.
Participants in the control group (Group 1) will receive the standard academy regimen for
initial presentation of Chronic OME, which is insertion of BMT. Group 2 trial subjects will
receive food allergy testing and management in conjunction with BMT. Group 3 involves BMT
insertion, adenoidectomy, and food allergy testing and management.
Food management involves parental education on how to avoid the specific offending foods by
their allergic children.
The total length of subject participation is variable depending on when the tubes come out.
Once the tubes have fallen out, the patient will be evaluated every three months for one
full year.
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.
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