Natural History of Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— EoE  

Official title:

Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290482
• Other study ID #: 17-002067
• Status: Completed
• Start date: June 19, 2017
• Est. completion date: March 25, 2020

Study information

• Verified date: August 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 25, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

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. — View Citation

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

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

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

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 1 year
Primary	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.	approximately 1 year
Primary	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.	approximately 1 year
Primary	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.	approximately 1 year

External Links

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