Mucosal Impedance and Eosinophilic Esophagitis

Not Applicable

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Device: Mucosal Impedance; Procedure: Upper Endoscopy

• Registration Number: NCT01953575
• Lead Sponsor: Mayo Clinic

Brief Summary

Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance?

And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Primary Completion: 2019-06-10
• Study Completion: 2019-06-10
• Status Verified: 2020-04
• Results First Submitted: 2020-04-01
• Results First Submitted QC: 2020-04-01
• Last Update Submitted: 2020-04-01
• Results First Posted: 2020-04-15
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inactive Eosinophilic Esophagitis	Mucosal Impedance	Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
Control group	Upper Endoscopy	Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy
Active Eosinophilic Esophagitis	Upper Endoscopy	Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
Active Eosinophilic Esophagitis	Mucosal Impedance	Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
Inactive Eosinophilic Esophagitis	Upper Endoscopy	Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy

Primary Outcome Measures

Name	Time	Method
Esophageal Mucosal Impedance (MI)	baseline to one year	An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States