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CompletedNCT03290482EoEUpdated Aug 12, 2021

Natural History of Eosinophilic Esophagitis

An observational study in Eosinophilic Esophagitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-12.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Eosinophilic Esophagitis
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Eosinophilic Esophagitis patients that we have been following for 10 years and participated in the previous study.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (actual)
Patient registry
No

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: 1. Evaluation by the PI physical examination 2. Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) questionnaires 3. Barium Esophagram with maximal and minimal esophageal diameter measurement 4. EsophaCap cytology

    Diagnostic Test: Barium Esophagram · Device: EsophaCap · Diagnostic Test: Physical Examination and Questionnaires

Interventions

  • Diagnostic testBarium 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.

  • DeviceEsophaCap

    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)

    Also known as: Sponge

  • Diagnostic testPhysical 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.

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What researchers measure

Primary outcomes

  1. Natural history of treated Eosinophilic Esophagitis (EE)

    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.

    Time frame: approximately 1 year

  2. Natural history of untreated Eosinophilic Esophagitis (EE)

    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.

    Time frame: approximately 1 year

  3. Natural history of treated Eosinophilic Esophagitis (EoE)

    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.

    Time frame: approximately 1 year

  4. Natural history of untreated Eosinophilic Esophagitis (EoE)

    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.

    Time frame: approximately 1 year

06

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
07

References and documents

Publications

  • Cherian S, Smith NM, Forbes DA. Rapidly increasing prevalence of eosinophilic oesophagitis in Western Australia. Arch Dis Child. 2006 Dec;91(12):1000-4. doi: 10.1136/adc.2006.100974. Epub 2006 Jul 28. PubMed 16877474 ↗
  • Landres RT, Kuster GG, Strum WB. Eosinophilic esophagitis in a patient with vigorous achalasia. Gastroenterology. 1978 Jun;74(6):1298-1301. PubMed 648822 ↗
  • Fox VL, Nurko S, Furuta GT. Eosinophilic esophagitis: it's not just kid's stuff. Gastrointest Endosc. 2002 Aug;56(2):260-70. doi: 10.1016/s0016-5107(02)70188-0. No abstract available. PubMed 12145607 ↗
  • 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. doi: 10.1053/j.gastro.2003.09.024. PubMed 14724818 ↗
  • Arora AS, Yamazaki K. Eosinophilic esophagitis: asthma of the esophagus? Clin Gastroenterol Hepatol. 2004 Jul;2(7):523-30. doi: 10.1016/s1542-3565(04)00236-8. PubMed 15224275 ↗
  • Noel RJ, Putnam PE, Rothenberg ME. Eosinophilic esophagitis. N Engl J Med. 2004 Aug 26;351(9):940-1. doi: 10.1056/NEJM200408263510924. No abstract available. PubMed 15329438 ↗
  • Straumann A, Simon HU. Eosinophilic esophagitis: escalating epidemiology? J Allergy Clin Immunol. 2005 Feb;115(2):418-9. doi: 10.1016/j.jaci.2004.11.006. No abstract available. PubMed 15696105 ↗
  • Morrow JB, Vargo JJ, Goldblum JR, Richter JE. The ringed esophagus: histological features of GERD. Am J Gastroenterol. 2001 Apr;96(4):984-9. doi: 10.1111/j.1572-0241.2001.03682.x. PubMed 11316216 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03290482
Lead sponsor
Mayo Clinic
Responsible party
Jeffrey A Alexander (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Sep 25, 2017
Start date
Jun 19, 2017
Primary completion
Nov 1, 2019
Completion
Mar 25, 2020
Last update
Aug 12, 2021

Study contacts

Jeffrey A Alexander, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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