Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population

NCT05176249 | Active Not Recruiting

• 1 other identifier: 2011-14486
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Eosinophilic Esophagitis (EoE) is a chronic, immune-mediated allergic inflammatory disorder that is being diagnosed with increased frequency. Compelling evidence suggests the etiopathogenesis is allergic and the immune response is triggered by food antigens in most children afflicted with this condition. The literature characterization of EoE is descriptive and retrospective thus far. Our aim in collecting and analyzing data prospectively of all EoE patients seen at Ann \& Robert H. Lurie Children's Hospital (Lurie Children's) is to better understand the etiology, pathogenesis and clinical presentation of EoE in patients to better delineate its association with other atopic conditions including reactive airway disease, seasonal allergies and atopic dermatitis. This will allow us to better evaluate the effectiveness of therapeutic strategies used to treat patients with EoE. In addition to collecting data prospectively, the investigators will also review the charts of EoE patients and those suspected of having EoE seen at Lurie Children's. This will allow us to also gather information on control patients, not diagnosed with EoE, who may not be followed in EoE clinic.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Perform a prospective analysis of all the EoE patients as well as patients suspected of having EoE

  to compare the efficacy of the different treatment modalities used in these patients to study the natural history of the disease.

  estimated every 6-12 months; at time of all standard of care endoscopies

Eligibility Criteria

• Age: 1 Month - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study population is determined through general GI and EOE specific clinics. Patients who are undergoing pre-diagnostic endoscopies to change of treatments are enrolled into this study.

You may qualify if:

• Patients with an established diagnosis of EoE, based on endoscopy with biopsies with ≥15 eosinophils per hpf in esophageal biopsies after symptoms of esophageal dysfunction persist despite at least 6-8 weeks of appropriate acid suppression therapy.
• Patients who are suspected of having EoE (presenting with symptoms of esophageal dysfunction non-responsive to appropriate proton pump inhibitor therapy for 6-8 weeks).
• Note: Patients suspected of having EoE but not diagnosed with EoE by endoscopy with biopsies will serve as control patients

You may not qualify if:

• Patients who do not consent to participate

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (10)

• 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.

  PMID: 17919504 BACKGROUND

• Dellon ES, Jensen ET, Martin CF, Shaheen NJ, Kappelman MD. Prevalence of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol. 2014 Apr;12(4):589-96.e1. doi: 10.1016/j.cgh.2013.09.008. Epub 2013 Sep 11.

  PMID: 24035773 BACKGROUND

• Soon IS, Butzner JD, Kaplan GG, deBruyn JC. Incidence and prevalence of eosinophilic esophagitis in children. J Pediatr Gastroenterol Nutr. 2013 Jul;57(1):72-80. doi: 10.1097/MPG.0b013e318291fee2.

  PMID: 23539047 BACKGROUND

• Ingle SB, Patle YG, Murdeshwar HG, Pujari GP. A case of early eosinophilic gastroenteritis with dramatic response to steroids. J Crohns Colitis. 2011 Feb;5(1):71-2. doi: 10.1016/j.crohns.2010.10.002. Epub 2010 Dec 18. No abstract available.

  PMID: 21272810 BACKGROUND

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

  PMID: 11468499 BACKGROUND

• Franciosi JP, Hommel KA, Bendo CB, King EC, Collins MH, Eby MD, Marsolo K, Abonia JP, von Tiehl KF, Putnam PE, Greenler AJ, Greenberg AB, Bryson RA, Davis CM, Olive AP, Gupta SK, Erwin EA, Klinnert MD, Spergel JM, Denham JM, Furuta GT, Rothenberg ME, Varni JW. PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity. J Pediatr Gastroenterol Nutr. 2013 Jul;57(1):57-66. doi: 10.1097/MPG.0b013e31828f1fd2.

  PMID: 23478422 BACKGROUND

• 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.

  PMID: 22099448 BACKGROUND

• Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.

  PMID: 11932914 BACKGROUND

• Varni JW, Seid M, Smith Knight T, Burwinkle T, Brown J, Szer IS. The PedsQL in pediatric rheumatology: reliability, validity, and responsiveness of the Pediatric Quality of Life Inventory Generic Core Scales and Rheumatology Module. Arthritis Rheum. 2002 Mar;46(3):714-25. doi: 10.1002/art.10095.

  PMID: 11920407 BACKGROUND

• 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.

  PMID: 26051952 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Intestinal Biopsies Store in RNAlater or AllProtect 2. Plasma or Serum from blood

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Joshua B Wechsler, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Gastroenterology, Hepatology & Nutrition

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: January 4, 2022
• Study Start: October 1, 2011
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)