Otitis Media With EffusionFATANCT00736112
Food Allergy - Tubes - Adenoids (FATA) Trial
A study testing Food Allergy Testing, Adenoidectomy and BMT in people with Otitis Media With Effusion and Food Hypersensitivity, run by University of Missouri-Columbia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Otitis Media With Effusion, Food Hypersensitivity
- What is being tested?
- Food Allergy Testing, Adenoidectomy and BMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Previous adenotonsillar surgery or placement of tympanostomy tubes.
- Children with inhalant allergies including asthma.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital: Department of Otolaryngology - Head and Neck Surgery
Columbia, Missouri, 65212
About this study
Official 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.
Read the detailed description
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.
- Conditions
- Otitis Media With Effusion, Food Hypersensitivity
- Being tested
- Food Allergy Testing, Adenoidectomy, BMT
- Keywords
- Food Allergy in Children, Otitis Media with Effusion (OME), Recurrent Middle Ear Infections, Middle Ear Fluid, Food Allergy and Otitis Media with Effusion, Recurrent middle ear fluid in children <4 years old, Chronic ear infections in children <4 years old
- Medical subject headings
- Otitis Media with Effusion, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Allergy TestingOther
Food Allergy Diagnosis - blood drawn for food allergy testing at the time of surgery (bilateral myringotomy with tympanostomy tubes +/- adenoidectomy)
AdenoidectomyProcedure or surgery
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?)
BMTProcedure or surgery
Also called Bilateral myringotomy with tympanostomy tubes
The standard protocol for children presenting with initial Chronic OME is to perform a BMT
| Study group | Role | What they receive |
|---|---|---|
| BMT and food allergy | Experimental | trial 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. Receives: Other: Food Allergy Testing; Procedure: BMT |
| BMT and adenoidectomy | Experimental | involves 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. Receives: Other: Food Allergy Testing; Procedure: Adenoidectomy; Procedure: BMT |
| BMT alone | Active comparator | The standard protocol for children presenting with initial Chronic OME is to perform a BMT (Bilateral Myringotomy with Tympanostomy Tubes). Receives: Procedure: BMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: The investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Paik, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736112
- Sponsor's protocol ID
- MU-ENT- 1120277
- Acronym
- FATA
- Status last verified
- Sep 2016
- First submitted
- 14 Aug 2008
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to Otitis Media With Effusion (OME)
- ClinicalTrials.gov ID
- NCT00736112
- Acronym / sponsor ID
- FATA / MU-ENT- 1120277
- Conditions
- Otitis Media With Effusion, Food Hypersensitivity
- Keywords
- Food Allergy in Children, Otitis Media with Effusion (OME), Recurrent Middle Ear Infections, Middle Ear Fluid, Food Allergy and Otitis Media with Effusion, Recurrent middle ear fluid in children <4 years old, Chronic ear infections in children <4 years old
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMT and food allergy | Experimental | Other: Food Allergy Testing, Procedure: BMTtrial 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 | Experimental | Other: Food Allergy Testing, Procedure: Adenoidectomy, Procedure: BMTinvolves 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 comparator | Procedure: BMTThe standard protocol for children presenting with initial Chronic OME is to perform a BMT (Bilateral Myringotomy with Tympanostomy Tubes). |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Previous adenotonsillar surgery or placement of tympanostomy tubes.
- Children with inhalant allergies including asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Allergy TestingFood Allergy Diagnosis - blood drawn for food allergy testing at the time of surgery (bilateral myringotomy with tympanostomy tubes +/- adenoidectomy) | Other | BMT and adenoidectomy, BMT and food allergy |
| AdenoidectomyAdenoidectomy 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 or surgery | BMT and adenoidectomy |
| BMTAlso: Bilateral myringotomy with tympanostomy tubesThe standard protocol for children presenting with initial Chronic OME is to perform a BMT | Procedure or surgery | BMT alone, BMT and adenoidectomy, BMT and food allergy |
Primary outcome
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).
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Paik, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Allergy Testing, Adenoidectomy and BMT in people with Otitis Media With Effusion and Food Hypersensitivity, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.