Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00736112
Status:
WITHDRAWN
Last Update Posted:
2016-09-30
First Post:
2008-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Allergy - Tubes - Adenoids (FATA) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010034', 'term': 'Otitis Media with Effusion'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000233', 'term': 'Adenoidectomy'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The investigator left the institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2008-08-14', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'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'], 'conditions': ['Otitis Media With Effusion', 'Food Hypersensitivity']}, 'descriptionModule': {'briefSummary': '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?"\n\nThe 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.\n\nTo 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.', 'detailedDescription': '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).\n\nEnd 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.\n\nMethodology: 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.\n\nProcedures: 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.\n\nParticipants 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.\n\nFood management involves parental education on how to avoid the specific offending foods by their allergic children.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Otoscopy reveals Chronic OME.\n2. Tympanometry confirms fluid in middle ear.\n3. Children \\<4 years old\n4. Lack of improvement after three months of antibiotic therapy.\n5. History of persistent effusion for three or more months per-episode of OM.\n6. \\>3 episodes of AOM in preceding 6 months or \\>5 episodes of AOM during preceding 12 months\n7. Bilateral conductive hearing loss of 15 dB or more.\n\nExclusion Criteria:\n\n1. Previous adenotonsillar surgery or placement of tympanostomy tubes.\n2. Children with inhalant allergies including asthma.'}, 'identificationModule': {'nctId': 'NCT00736112', 'acronym': 'FATA', 'briefTitle': 'Food Allergy - Tubes - Adenoids (FATA) Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'A New Approach to Otitis Media With Effusion (OME)', 'orgStudyIdInfo': {'id': 'MU-ENT- 1120277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMT and food allergy', 'description': '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.', 'interventionNames': ['Other: Food Allergy Testing', 'Procedure: BMT']}, {'type': 'EXPERIMENTAL', 'label': 'BMT and adenoidectomy', 'description': 'involves BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and food allergy testing and management.\n\nFood allergy management involves parental education on how to avoid the specific offending foods.', 'interventionNames': ['Other: Food Allergy Testing', 'Procedure: Adenoidectomy', 'Procedure: BMT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMT alone', 'description': 'The standard protocol for children presenting with initial Chronic OME is to perform a BMT (Bilateral Myringotomy with Tympanostomy Tubes).', 'interventionNames': ['Procedure: BMT']}], 'interventions': [{'name': 'Food Allergy Testing', 'type': 'OTHER', 'description': 'Food Allergy Diagnosis - blood drawn for food allergy testing at the time of surgery (bilateral myringotomy with tympanostomy tubes +/- adenoidectomy)', 'armGroupLabels': ['BMT and adenoidectomy', 'BMT and food allergy']}, {'name': 'Adenoidectomy', 'type': 'PROCEDURE', 'description': '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?)', 'armGroupLabels': ['BMT and adenoidectomy']}, {'name': 'BMT', 'type': 'PROCEDURE', 'otherNames': ['Bilateral myringotomy with tympanostomy tubes'], 'description': 'The standard protocol for children presenting with initial Chronic OME is to perform a BMT', 'armGroupLabels': ['BMT alone', 'BMT and adenoidectomy', 'BMT and food allergy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University Hospital: Department of Otolaryngology - Head and Neck Surgery', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Young Paik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}