Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-08-08
2023-05-31
Brief Summary
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Detailed Description
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The study would involve children ages 3-17 years with biopsy-proven EoE who have a known flare-inducing food trigger. Following baseline blood work and esophagogastroduodenoscopy (EGD), the investigators will initiate oral desensitization treatment in which the child swallows a spray solution containing his or her specific food allergen extract in increasing concentrations twice daily for 4 months. The next phase of the study would involve reintroduction of the actual food for 4 weeks followed by repeat blood work and EGD. Success would be defined by having a peak eosinophil count \<15 per high power field on the final esophageal biopsy.
Oral food desensitization has been well-studied in patients with food allergies but never in patients with pre-existing EoE. In those studies, the adverse events included mild reactions, such as watery eyes, rhinitis, sneezing, throat pruritus, transient erythema and abdominal pain. These reactions usually did not require stopping desensitization and were well controlled by antihistamines and steroids. Benefits include children having a less restricted diet and eliminating the need for steroid therapy. This study should yield valuable information regarding the management of EoE, thereby improving the current understanding of its pathogenesis.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Oral food desensitization
All of the children enrolled in the study will receive oral food desensitization with his or her specific EoE flare-inducing food antigen (e.g. cow's milk protein). The food antigen will be diluted in a 50% glycerin/water solution containing ascorbic acid (Vitamin C) to stabilize and preserve the solution. This oral spray will need to be administered twice a day, every day for a total of 4 months.
Oral food desensitization
The child's specific food antigen will be diluted in a 50% glycerin/water solution containing ascorbic acid (Vitamin C). This oral spray solution will need to be administered twice a day, every day for a total of 4 months
Interventions
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Oral food desensitization
The child's specific food antigen will be diluted in a 50% glycerin/water solution containing ascorbic acid (Vitamin C). This oral spray solution will need to be administered twice a day, every day for a total of 4 months
Eligibility Criteria
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Inclusion Criteria
2. Known or suspected flare-inducing food trigger based upon supporting histological evidence.
3. Already undergoing a baseline EGD followed by food reintroduction and repeat EGD, as standard of care at the recommendation of the child's gastroenterologist.
4. Signed informed consent for the subject's participation in the study provided by the parent/ legal guardian and child/adolescent assent for subjects 7-17 years.
5. Assent by the patient's pediatric gastroenterologist for the patient's participation in the study.
Exclusion Criteria
2. Previous or current diagnosis of cancer or leukemia.
3. History of chemotherapy within the past 3 months.
4. History of esophageal stricture or food impaction.
5. History of anaphylaxis or other severe adverse reaction to the specific food trigger being tested.
3 Years
17 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Tu Thanh Mai
Assistant Professor
Principal Investigators
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Marc Rhoads, MD
Role: STUDY_DIRECTOR
University of Texas
Locations
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University of Texas Health Science Center
Houston, Texas, United States
Countries
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References
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Furuta GT, Liacouras CA, Collins MH, Gupta SK, Justinich C, Putnam PE, Bonis P, Hassall E, Straumann A, Rothenberg ME; First International Gastrointestinal Eosinophil Research Symposium (FIGERS) Subcommittees. Eosinophilic esophagitis in children and adults: a systematic review and consensus recommendations for diagnosis and treatment. Gastroenterology. 2007 Oct;133(4):1342-63. doi: 10.1053/j.gastro.2007.08.017. Epub 2007 Aug 8.
Gupta SK. Noninvasive markers of eosinophilic esophagitis. Gastrointest Endosc Clin N Am. 2008 Jan;18(1):157-67; xi. doi: 10.1016/j.giec.2007.09.004.
Arias A, Perez-Martinez I, Tenias JM, Lucendo AJ. Systematic review with meta-analysis: the incidence and prevalence of eosinophilic oesophagitis in children and adults in population-based studies. Aliment Pharmacol Ther. 2016 Jan;43(1):3-15. doi: 10.1111/apt.13441. Epub 2015 Oct 28.
Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693. doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9.
Cianferoni A, Spergel JM. Immunotherapeutic approaches for the treatment of eosinophilic esophagitis. Immunotherapy. 2014;6(3):321-31. doi: 10.2217/imt.14.3.
Simon D, Cianferoni A, Spergel JM, Aceves S, Holbreich M, Venter C, Rothenberg ME, Terreehorst I, Muraro A, Lucendo AJ, Schoepfer A, Straumann A, Simon HU. Eosinophilic esophagitis is characterized by a non-IgE-mediated food hypersensitivity. Allergy. 2016 May;71(5):611-20. doi: 10.1111/all.12846. Epub 2016 Feb 25.
Schlag C, Miehlke S, Heiseke A, Brockow K, Krug A, von Arnim U, Straumann A, Vieth M, Bussmann C, Mueller R, Greinwald R, Bajbouj M. Peripheral blood eosinophils and other non-invasive biomarkers can monitor treatment response in eosinophilic oesophagitis. Aliment Pharmacol Ther. 2015 Nov;42(9):1122-30. doi: 10.1111/apt.13386. Epub 2015 Aug 27.
Kagalwalla AF, Shah A, Li BU, Sentongo TA, Ritz S, Manuel-Rubio M, Jacques K, Wang D, Melin-Aldana H, Nelson SP. Identification of specific foods responsible for inflammation in children with eosinophilic esophagitis successfully treated with empiric elimination diet. J Pediatr Gastroenterol Nutr. 2011 Aug;53(2):145-9. doi: 10.1097/MPG.0b013e31821cf503.
Molina-Infante J, Arias A, Barrio J, Rodriguez-Sanchez J, Sanchez-Cazalilla M, Lucendo AJ. Four-food group elimination diet for adult eosinophilic esophagitis: A prospective multicenter study. J Allergy Clin Immunol. 2014 Nov;134(5):1093-9.e1. doi: 10.1016/j.jaci.2014.07.023. Epub 2014 Aug 28.
Spergel JM, Shuker M. Nutritional management of eosinophilic esophagitis. Gastrointest Endosc Clin N Am. 2008 Jan;18(1):179-94; xi. doi: 10.1016/j.giec.2007.09.008.
Pajno GB, Cox L, Caminiti L, Ramistella V, Crisafulli G. Oral Immunotherapy for Treatment of Immunoglobulin E-Mediated Food Allergy: The Transition to Clinical Practice. Pediatr Allergy Immunol Pulmonol. 2014 Jun 1;27(2):42-50. doi: 10.1089/ped.2014.0332.
Howie SR. Blood sample volumes in child health research: review of safe limits. Bull World Health Organ. 2011 Jan 1;89(1):46-53. doi: 10.2471/BLT.10.080010. Epub 2010 Sep 10.
Martin LJ, Franciosi JP, Collins MH, Abonia JP, Lee JJ, Hommel KA, Varni JW, Grotjan JT, Eby M, He H, Marsolo K, Putnam PE, Garza JM, Kaul A, Wen T, Rothenberg ME. Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS v2.0) identify histologic and molecular correlates of the key clinical features of disease. J Allergy Clin Immunol. 2015 Jun;135(6):1519-28.e8. doi: 10.1016/j.jaci.2015.03.004.
Franciosi JP, Hommel KA, DeBrosse CW, Greenberg AB, Greenler AJ, Abonia JP, Rothenberg ME, Varni JW. Development of a validated patient-reported symptom metric for pediatric eosinophilic esophagitis: qualitative methods. BMC Gastroenterol. 2011 Nov 18;11:126. doi: 10.1186/1471-230X-11-126.
Peters RL, Dang TD, Allen KJ. Specific oral tolerance induction in childhood. Pediatr Allergy Immunol. 2016 Dec;27(8):784-794. doi: 10.1111/pai.12620. Epub 2016 Sep 16.
Spergel JM, Brown-Whitehorn TF, Beausoleil JL, Franciosi J, Shuker M, Verma R, Liacouras CA. 14 years of eosinophilic esophagitis: clinical features and prognosis. J Pediatr Gastroenterol Nutr. 2009 Jan;48(1):30-6. doi: 10.1097/MPG.0b013e3181788282.
Lucendo AJ, Sanchez-Cazalilla M. Adult versus pediatric eosinophilic esophagitis: important differences and similarities for the clinician to understand. Expert Rev Clin Immunol. 2012 Nov;8(8):733-45. doi: 10.1586/eci.12.68.
Related Links
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Select Committee on GRAS Substances (SCOGS) Opinion: L-ascorbic acid, sodium L-ascorbate, calcium L-ascorbate, ascorbyl palmitate (palmitoyl L-ascorbic), erythorbic acid (D-isoascorbic acid), and sodium erythorbate (sodium D-isoascorbate)
Other Identifiers
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HSC-MS-17-0391
Identifier Type: -
Identifier Source: org_study_id
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