Study Summary
This trial is testing whether it's safe to desensitize kids with EoE to their trigger food, with the hope that it will be effective.
Eligible Conditions
- Eosinophilic Esophagitis
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 5 months
5 months
Peak eosinophil count on esophageal biopsy
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Oral food desensitization
1 of 1
Experimental Treatment
5 Total Participants · 1 Treatment Group
Primary Treatment: Oral food desensitization · No Placebo Group · N/A
Oral food desensitization
Other
Experimental Group · 1 Intervention: Oral food desensitization · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 months
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
835 Previous Clinical Trials
263,912 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
164 Patients Enrolled for Eosinophilic Esophagitis
Marc Rhoads, MDStudy DirectorUniversity of Texas
Eligibility Criteria
Age 3 - 17 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have already undergone a standard medical procedure called an EGD, and your doctor has recommended that you repeat the procedure after reintroducing food.
References
- Gupta, Sandeep K.. 2008. “Noninvasive Markers of Eosinophilic Esophagitis”. Gastrointestinal Endoscopy Clinics of North America. Elsevier BV. doi:10.1016/j.giec.2007.09.004.
- Martin, Lisa J., James P. Franciosi, Margaret H. Collins, J. Pablo Abonia, James J. Lee, Kevin A. Hommel, James W. Varni, et al.. 2015. “Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS V2.0) Identify Histologic and Molecular Correlates of the Key Clinical Features of Disease”. Journal of Allergy and Clinical Immunology. Elsevier BV. doi:10.1016/j.jaci.2015.03.004.
- Arias, Á., I. Pérez-Martínez, J. M. Tenías, and A. J. Lucendo. 2015. “Systematic Review with Meta-analysis: The Incidence and Prevalence of Eosinophilic Oesophagitis in Children and Adults in Population-based Studies”. Alimentary Pharmacology & Therapeutics. Wiley. doi:10.1111/apt.13441.
- Simon, D., A. Cianferoni, J. M. Spergel, S. Aceves, M. Holbreich, C. Venter, M. E. Rothenberg, et al.. 2016. “Eosinophilic Esophagitis Is Characterized by a Non-ige-mediated Food Hypersensitivity”. Allergy. Wiley. doi:10.1111/all.12846.
- Franciosi, James P, Kevin A Hommel, Charles W DeBrosse, Allison B Greenberg, Alexandria J Greenler, J Pablo Abonia, Marc E Rothenberg, and James W Varni. 2011. “Development of a Validated Patient-reported Symptom Metric for Pediatric Eosinophilic Esophagitis: Qualitative Methods”. BMC Gastroenterology. Springer Science and Business Media LLC. doi:10.1186/1471-230x-11-126.
- Lucendo, Alfredo J, and Marta Sánchez-Cazalilla. 2012. “Adult Versus Pediatric Eosinophilic Esophagitis: Important Differences and Similarities for the Clinician to Understand”. Expert Review of Clinical Immunology. Informa UK Limited. doi:10.1586/eci.12.68.
- Peters, Rachel L., Thanh D. Dang, and Katrina J. Allen. 2016. “Specific Oral Tolerance Induction in Childhood”. Pediatric Allergy and Immunology. Wiley. doi:10.1111/pai.12620.
- Spergel, Jonathan M, Terri F Brown-Whitehorn, Janet L Beausoleil, James Franciosi, Michele Shuker, Ritu Verma, and Chris A Liacouras. 2009. “14 Years of Eosinophilic Esophagitis: Clinical Features and Prognosis”. Journal of Pediatric Gastroenterology & Nutrition. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpg.0b013e3181788282.
- Cianferoni, Antonella, and Jonathan M Spergel. 2014. “Immunotherapeutic Approaches for the Treatment of Eosinophilic Esophagitis”. Immunotherapy. Future Medicine Ltd. doi:10.2217/imt.14.3.
- Schlag, C., S. Miehlke, A. Heiseke, K. Brockow, A. Krug, U. von Arnim, A. Straumann, et al.. 2015. “Peripheral Blood Eosinophils and Other Non-invasive Biomarkers Can Monitor Treatment Response in Eosinophilic Oesophagitis”. Alimentary Pharmacology & Therapeutics. Wiley. doi:10.1111/apt.13386.
- Pajno, Giovanni B., Linda Cox, Lucia Caminiti, Vincenzo Ramistella, and Giuseppe Crisafulli. 2014. “Oral Immunotherapy for Treatment of Immunoglobulin E-mediated Food Allergy: The Transition to Clinical Practice”. Pediatric Allergy, Immunology, and Pulmonology. Mary Ann Liebert Inc. doi:10.1089/ped.2014.0332.
- Dellon, Evan S, Nirmala Gonsalves, Ikuo Hirano, Glenn T Furuta, Chris A Liacouras, and David A Katzka. 2013. “ACG Clinical Guideline: Evidenced Based Approach to the Diagnosis and Management of Esophageal Eosinophilia and Eosinophilic Esophagitis (eoe)”. American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1038/ajg.2013.71.
- Kagalwalla, Amir F., Ameesh Shah, B U.K. Li, Timothy A. Sentongo, Sally Ritz, Maria Manuel-Rubio, Katie Jacques, Deli Wang, Hector Melin-Aldana, and Suzanne P. Nelson. 2011. “Identification of Specific Foods Responsible for Inflammation in Children with Eosinophilic Esophagitis Successfully Treated with Empiric Elimination Diet”. Journal of Pediatric Gastroenterology & Nutrition. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpg.0b013e31821cf503.
- Molina-Infante, Javier, Angel Arias, Jesus Barrio, Joaquín Rodríguez-Sánchez, Marta Sanchez-Cazalilla, and Alfredo J. Lucendo. 2014. “Four-food Group Elimination Diet for Adult Eosinophilic Esophagitis: A Prospective Multicenter Study”. Journal of Allergy and Clinical Immunology. Elsevier BV. doi:10.1016/j.jaci.2014.07.023.
- Furuta, Glenn T., Chris A. Liacouras, Margaret H. Collins, Sandeep K. Gupta, Chris Justinich, Phil E. Putnam, Peter Bonis, Eric Hassall, Alex Straumann, and Marc E. Rothenberg. 2007. “Eosinophilic Esophagitis in Children and Adults: A Systematic Review and Consensus Recommendations for Diagnosis and Treatment”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2007.08.017.
- Howie, Stephen RC. 2010. “Blood Sample Volumes in Child Health Research: Review of Safe Limits”. Bulletin of the World Health Organization. WHO Press. doi:10.2471/blt.10.080010.
- Spergel, Jonathan M., and Michele Shuker. 2008. “Nutritional Management of Eosinophilic Esophagitis”. Gastrointestinal Endoscopy Clinics of North America. Elsevier BV. doi:10.1016/j.giec.2007.09.008.
- Dellon, Evan S, Nirmala Gonsalves, Ikuo Hirano, Glenn T Furuta, Chris A Liacouras, and David A Katzka. 2013. “ACG Clinical Guideline: Evidenced Based Approach to the Diagnosis and Management of Esophageal Eosinophilia and Eosinophilic Esophagitis (eoe)”. American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1038/ajg.2013.71.
- 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.
- 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.
- 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.
- Cianferoni A, Spergel JM. Immunotherapeutic approaches for the treatment of eosinophilic esophagitis. Immunotherapy. 2014;6(3):321-31. doi: 10.2217/imt.14.3.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Tu Thanh Mai 2018. "EoE Food Desensitization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02881372.
Frequently Asked Questions
What are the qualifications for enrollment in this clinical experiment?
"The study requires participants between 3 and 17 years old to be diagnosed with eosinophilic esophagitis. Five children will be recruited in total." - Anonymous Online Contributor
Unverified Answer
Does this clinical trial extend to elderly participants over the age of 65?
"The desired age range for participants of this research is between 3 and 17 years old." - Anonymous Online Contributor
Unverified Answer
What is the aggregate number of participants involved in this clinical trial?
"Yes, the public records found on clinicaltrials.gov demonstrate that this experiment is actively recruiting patients. This trial was originally posted in August of 2018 and has since been modified as recently as June 2021 with a target enrolment of 5 participants from one site." - Anonymous Online Contributor
Unverified Answer
Is this research endeavor recruiting new participants currently?
"Affirmative. Data hosted on clinicaltrials.gov points to the fact that this medical trial, whose inception was August 8th 2018, is now actively looking for individuals to take part in it. The team needs 5 participants from a single medical centre." - Anonymous Online Contributor
Unverified Answer