NCT03342391

CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic Esophagitis in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 5 Years – 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients.

Detailed description

A participant with an established diagnosis of EoE who is undergoing Standard of Care treatment with a four or less food elimination diet (not including or counting foods restricted at time of EoE diagnosis) OR is on topical swallowed steroid therapy with any number of foods eliminated from the diet, is in histological remission, and has been recommended as part of Standard of Care to start a single new food introduction OR remove the swallowed steroid treatment by the subject's clinical allergist or gastroenterologist will be enrolled in the study. 14-17 days after the introduction of the clinically recommended single food antigen, a TNE will be performed to assess the esophageal mucosa. TNE will be performed every 2 weeks for six weeks (3 total TNE) to evaluate recurrence time of mucosal eosinophilia (\>15 eos/HPF), other histological changes, and patient tolerance to serial TNE. At week 6 a sedated esophagoscopy will be offered as an alternative choice to TNE if the participant chooses.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
OTHER	Transnasal esophagoscopy	single food antigen introduction OR removal of topical swallowed steroid therapy followed by surveillance utilizing TNE

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-08-31
• Completion: 2020-09-01
• First posted: 2017-11-17
• Last updated: 2021-03-09

Locations

1 site across 1 country: United States