NCT03290482

Natural History of Eosinophilic Esophagitis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-19
• Primary completion: 2019-11-01
• Completion: 2020-03-25
• First posted: 2017-09-25
• Last updated: 2021-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study