- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03290482
Natural History of Eosinophilic Esophagitis (EoE)
August 5, 2021 updated by: Jeffrey A Alexander, Mayo Clinic
Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years
Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Eosinophilic Esophagitis patients that we have been following for 10 years and participated in the previous study.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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:
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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.
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)
Other Names:
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 is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Natural history of treated Eosinophilic Esophagitis (EE)
Time Frame: approximately 1 year
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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.
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approximately 1 year
|
Natural history of untreated Eosinophilic Esophagitis (EE)
Time Frame: approximately 1 year
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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.
|
approximately 1 year
|
Natural history of treated Eosinophilic Esophagitis (EoE)
Time Frame: approximately 1 year
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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.
|
approximately 1 year
|
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.
|
approximately 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey A Alexander, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1016/s0016-5107(02)70188-0. No abstract available.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2017
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
March 25, 2020
Study Registration Dates
First Submitted
August 24, 2017
First Submitted That Met QC Criteria
September 19, 2017
First Posted (Actual)
September 25, 2017
Study Record Updates
Last Update Posted (Actual)
August 12, 2021
Last Update Submitted That Met QC Criteria
August 5, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-002067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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