Mucosal Impedance and Eosinophilic Esophagitis (EoE)

Mayo Clinic

Status: Completed

Conditions: Eosinophilic Esophagitis

Treatments: Procedure: Upper Endoscopy; Device: Mucosal Impedance

Study type: Interventional

Funder types: Other

Identifiers

NCT01953575

13-005778

Details and patient eligibility

About

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?

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ages 18-90 undergoing clinically indicated upper endoscopy
• Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
• Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or Gastroesophageal reflux disease (GERD) with normal appearing esophageal mucosa.

Exclusion criteria

• Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
• Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
• Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups, including a placebo group

Active Eosinophilic Esophagitis

Experimental group

Description:

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

Treatment:

Device: Mucosal Impedance

Procedure: Upper Endoscopy

Inactive Eosinophilic Esophagitis

Experimental group

Description:

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

Treatment:

Device: Mucosal Impedance

Procedure: Upper Endoscopy

Control group

Placebo Comparator group

Description:

Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy

Treatment:

Procedure: Upper Endoscopy