Eosinophilic Gastrointestinal Disorders Registry

NCT05199532 | Recruiting

• 1 other identifier: 2020-3601
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about Eosinophilic Gastrointestinal Disorders (EGIDs). With this registry we hope to find out more about the symptoms that patients have during their treatment, the quality of life they have with the diagnosis, what the disease looks like throughout the different treatment methods, and if there is a connection between EGIDs and connective tissue disorders. The goal of this study is to be able to better understand EGIDs and use information gained from all the information collected on this study for more precise treatments in the future. We want to create a large collection of samples, called a biorepository, to learn the most about EGIDs as possible. When the samples are collected, which will occur at procedures directed by your child's doctor as part of their standard of care, they will be stored for an unlimited amount of time to perform experiments on these samples and to gather information about EGIDs

Conditions

Eosinophilic Esophagitis; Eosinophilic Gastroenteritis; Eosinophilic Colitis; Eosinophilic Gastrointestinal Disease

Outcome Measures

Primary Outcomes (5)

• Clinical/Patient-Reported Measures

  Families complete questionnaires regarding reported symptoms and quality of life as well as family history, patient history and dietary checklists. Change in responses will be assessed at collection timepoints

  through study completion, an average of 6 months to 1 year

• Endoscopic measures

  Endoscopy visual findings will be evaluated using EREFS measurements, which measure the visual findings of Exudates, Rings, Edema, Furrows, and Strictures

  through study completion, an average of 6 months to 1 year

• Physical exam findings

  hypermobility as assessed by Beighton Score, assessed from 5 questions on a 0-2 scale with a higher score reporting a positive association with hypermobility

  through study completion, an average of 6 months to 1 year

• Histologic features

  Histology markers of eosinophilic esophagitis, specifically eos/hpf, will be assessed at standard of care endoscopies to show change throughout study participation

  through study completion, an average of 6 months to 1 year

• Molecular measures

  In particular, we will assess mast cells and t-cells, and their mediators that are increased in EGIDs

  through study completion, an average of 6 months to 1 year

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects of this study include patients followed at Lurie Children's Hospital for evaluation or treatment of an EGID. Patients receiving care at Lurie Children's hospital include residents of the greater Chicago area, as well as patients throughout the Midwest seeking care at a tertiary referral center. Patients suspected of having EGID present with a wide variety of symptoms, ranging from classic symptoms of EoE including dysphagia and food impaction, to more general symptoms of abdominal pain, heartburn, vomiting, food refusal, failure to thrive, and diarrhea. Diagnostic criteria for EGIDs rely on clinical symptoms and the presence of eosinophil-predominant inflammation on biopsy.

You may qualify if:

• Patients with an established diagnosis of an EGID, based on pathology findings from an endoscopy or colonoscopy with biopsies.
• Patients suspected of having an EGID and undergoing endoscopic evaluation for further assessment

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

RECRUITING

Related Publications (12)

• Dellon ES, Hirano I. Epidemiology and Natural History of Eosinophilic Esophagitis. Gastroenterology. 2018 Jan;154(2):319-332.e3. doi: 10.1053/j.gastro.2017.06.067. Epub 2017 Aug 1.

  PMID: 28774845 BACKGROUND

• O'Shea KM, Aceves SS, Dellon ES, Gupta SK, Spergel JM, Furuta GT, Rothenberg ME. Pathophysiology of Eosinophilic Esophagitis. Gastroenterology. 2018 Jan;154(2):333-345. doi: 10.1053/j.gastro.2017.06.065. Epub 2017 Jul 27.

  PMID: 28757265 BACKGROUND

• Jensen ET, Kappelman MD, Martin CF, Dellon ES. Health-care utilization, costs, and the burden of disease related to eosinophilic esophagitis in the United States. Am J Gastroenterol. 2015 May;110(5):626-32. doi: 10.1038/ajg.2014.316. Epub 2014 Sep 30.

  PMID: 25267327 BACKGROUND

• Furuta GT, Katzka DA. Eosinophilic Esophagitis. N Engl J Med. 2015 Oct 22;373(17):1640-8. doi: 10.1056/NEJMra1502863.

  PMID: 26488694 BACKGROUND

• Steinbach EC, Hernandez M, Dellon ES. Eosinophilic Esophagitis and the Eosinophilic Gastrointestinal Diseases: Approach to Diagnosis and Management. J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1483-1495. doi: 10.1016/j.jaip.2018.06.012. Epub 2018 Jul 3.

  PMID: 30201096 BACKGROUND

• Dellon ES, Liacouras CA, Molina-Infante J, Furuta GT, Spergel JM, Zevit N, Spechler SJ, Attwood SE, Straumann A, Aceves SS, Alexander JA, Atkins D, Arva NC, Blanchard C, Bonis PA, Book WM, Capocelli KE, Chehade M, Cheng E, Collins MH, Davis CM, Dias JA, Di Lorenzo C, Dohil R, Dupont C, Falk GW, Ferreira CT, Fox A, Gonsalves NP, Gupta SK, Katzka DA, Kinoshita Y, Menard-Katcher C, Kodroff E, Metz DC, Miehlke S, Muir AB, Mukkada VA, Murch S, Nurko S, Ohtsuka Y, Orel R, Papadopoulou A, Peterson KA, Philpott H, Putnam PE, Richter JE, Rosen R, Rothenberg ME, Schoepfer A, Scott MM, Shah N, Sheikh J, Souza RF, Strobel MJ, Talley NJ, Vaezi MF, Vandenplas Y, Vieira MC, Walker MM, Wechsler JB, Wershil BK, Wen T, Yang GY, Hirano I, Bredenoord AJ. Updated International Consensus Diagnostic Criteria for Eosinophilic Esophagitis: Proceedings of the AGREE Conference. Gastroenterology. 2018 Oct;155(4):1022-1033.e10. doi: 10.1053/j.gastro.2018.07.009. Epub 2018 Sep 6.

  PMID: 30009819 BACKGROUND

• Godwin B, Wilkins B, Muir AB. EoE disease monitoring: Where we are and where we are going. Ann Allergy Asthma Immunol. 2020 Mar;124(3):240-247. doi: 10.1016/j.anai.2019.12.004. Epub 2019 Dec 9.

  PMID: 31830586 BACKGROUND

• Carlson DA, Lin Z, Hirano I, Gonsalves N, Zalewski A, Pandolfino JE. Evaluation of esophageal distensibility in eosinophilic esophagitis: an update and comparison of functional lumen imaging probe analytic methods. Neurogastroenterol Motil. 2016 Dec;28(12):1844-1853. doi: 10.1111/nmo.12888. Epub 2016 Jun 16.

  PMID: 27311807 BACKGROUND

• Abonia JP, Wen T, Stucke EM, Grotjan T, Griffith MS, Kemme KA, Collins MH, Putnam PE, Franciosi JP, von Tiehl KF, Tinkle BT, Marsolo KA, Martin LJ, Ware SM, Rothenberg ME. High prevalence of eosinophilic esophagitis in patients with inherited connective tissue disorders. J Allergy Clin Immunol. 2013 Aug;132(2):378-86. doi: 10.1016/j.jaci.2013.02.030. Epub 2013 Apr 19.

  PMID: 23608731 BACKGROUND

• Tinkle BT, Levy HP. Symptomatic Joint Hypermobility: The Hypermobile Type of Ehlers-Danlos Syndrome and the Hypermobility Spectrum Disorders. Med Clin North Am. 2019 Nov;103(6):1021-1033. doi: 10.1016/j.mcna.2019.08.002.

  PMID: 31582002 BACKGROUND

• Huang KZ, Dellon ES. Increased prevalence of autonomic dysfunction due to postural orthostatic tachycardia syndrome in patients with eosinophilic gastrointestinal disorders. J Gastrointestin Liver Dis. 2019 Mar;28(1):47-51. doi: 10.15403/jgld.2014.1121.281.syd.

  PMID: 30851172 BACKGROUND

• Fikree A, Aziz Q, Sifrim D. Mechanisms underlying reflux symptoms and dysphagia in patients with joint hypermobility syndrome, with and without postural tachycardia syndrome. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13029. Epub 2017 Feb 12.

  PMID: 28191707 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Biopsies stored in AllProtect 2. Whole Blood

MeSH Terms

Conditions

Eosinophilic Esophagitis; Eosinophilic enteropathy

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

Central Study Contacts

Angela Anthony

CONTACT

312-227-4559; aanthony@luriechildrens.org

Mary Riordan

CONTACT

312-227-4558; mriordan@luriechildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: January 20, 2022
• Study Start: December 18, 2020
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)