Natural History of Eosinophilic Esophagitis

Overview

Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.

Full Title of Study: “Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 1, 2021

Detailed Description

Investigators will identify patients from their database who have been diagnosed with Eosinophilic Esophagitis (EE) from the study period 2000 to 2008, based on clinical features and biopsy findings. Participants will be offered a follow up evaluation that includes: evaluation by the Principal Investigator, completion of questionnaires, Esophagram and Esophageal sponge (EsophaCap) cytology.

Interventions

  • Diagnostic Test: Barium Esophagram
    • Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes.
  • Device: EsophaCap
    • Subjects will swallow the EsophaCap, which has a string attached, 10 minutes later it has devolved in the stomach. The PI will pull the string to remove the EsophaCap. We will send the sponge for cytology assessing the histologic results of eosinophils per high power field (phf)
  • Diagnostic Test: Physical Examination and Questionnaires
    • Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.

Arms, Groups and Cohorts

  • EE Study Patients 2000-2008
    • All patients with the diagnosis of EE from the study period 2000 to 2008. Sixty patients participated in the 10 year follow up phone interview and questionnaire. These are the subjects we will contact to see if they are interested in participating in this study. If interested in participating, subjects will complete: Evaluation by the PI physical examination Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) questionnaires Barium Esophagram with maximal and minimal esophageal diameter measurement EsophaCap cytology

Clinical Trial Outcome Measures

Primary Measures

  • Natural history of treated Eosinophilic Esophagitis (EE)
    • Time Frame: approximately 1 year
    • The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 – item instrument in which symptoms are divided into three symptom domains.
  • Natural history of untreated Eosinophilic Esophagitis (EE)
    • Time Frame: approximately 1 year
    • The number of recurrent symptoms using the modified Mayo Dysphagia Questionnaire (MDQ). The MDQ is a 32 – item instrument in which symptoms are divided into three symptom domains.
  • Natural history of treated Eosinophilic Esophagitis (EoE)
    • Time Frame: approximately 1 year
    • The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.
  • Natural history of untreated Eosinophilic Esophagitis (EoE)
    • Time Frame: approximately 1 year
    • The number of recurrent symptoms using the Eosinophilic Esophagitis Activity Index (EEsAI). The EEsAI provides a visual analogue of foods for subjects to examine and rate for difficulty in swallowing ranging from severe difficulties to No difficulties.

Participating in This Clinical Trial

Inclusion Criteria

  • Adults 18 years of age and older
  • Previous participation in the natural history followup study

Exclusion Criteria

  • Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
  • Pregnant women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeffrey A Alexander, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Jeffrey A Alexander, MD, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Debra M Geno, CCRP, 507-538-0367, geno.debra@mayo.edu

References

Cherian S, Smith NM, Forbes DA. Rapidly increasing prevalence of eosinophilic oesophagitis in Western Australia. Arch Dis Child. 2006 Dec;91(12):1000-4. Epub 2006 Jul 28.

Landres RT, Kuster GG, Strum WB. Eosinophilic esophagitis in a patient with vigorous achalasia. Gastroenterology. 1978 Jun;74(6):1298-1301.

Fox VL, Nurko S, Furuta GT. Eosinophilic esophagitis: it's not just kid's stuff. Gastrointest Endosc. 2002 Aug;56(2):260-70. Review.

Straumann A, Spichtin HP, Grize L, Bucher KA, Beglinger C, Simon HU. Natural history of primary eosinophilic esophagitis: a follow-up of 30 adult patients for up to 11.5 years. Gastroenterology. 2003 Dec;125(6):1660-9.

Arora AS, Yamazaki K. Eosinophilic esophagitis: asthma of the esophagus? Clin Gastroenterol Hepatol. 2004 Jul;2(7):523-30. Review.

Noel RJ, Putnam PE, Rothenberg ME. Eosinophilic esophagitis. N Engl J Med. 2004 Aug 26;351(9):940-1.

Straumann A, Simon HU. Eosinophilic esophagitis: escalating epidemiology? J Allergy Clin Immunol. 2005 Feb;115(2):418-9.

Morrow JB, Vargo JJ, Goldblum JR, Richter JE. The ringed esophagus: histological features of GERD. Am J Gastroenterol. 2001 Apr;96(4):984-9.

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