Natural History of Eosinophilic Esophagitis

NCT ID: NCT03290482

Last Updated: 2021-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-19

Study Completion Date

2020-03-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Eosinophilic Esophagitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Barium Esophagram

Intervention Type DIAGNOSTIC_TEST

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.

EsophaCap

Intervention Type DEVICE

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)

Physical Examination and Questionnaires

Intervention Type DIAGNOSTIC_TEST

Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DEVICE

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Sponge

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey A Alexander

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey A Alexander, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16877474 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 648822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12145607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14724818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15224275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15329438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15696105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11316216 (View on PubMed)

Related Links

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Other Identifiers

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17-002067

Identifier Type: -

Identifier Source: org_study_id

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