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

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

Study Overview

• Status: Completed
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Other: Transnasal esophagoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant must be able to understand and provide informed consent/assent
2. Males and females ages 5-22 years of age
3. History of an established diagnosis of EoE
4. Recent EGD or TNE (with in past 1 year) showing EoE remission (e.g. <15 x eosinophils/hpf) and currently without significant symptoms attributed to EoE.
5. On a four food or less elimination diet not including or counting foods restricted at time of EoE diagnosis OR on swallowed topical steroid therapy with any number of foods eliminated from the diet.
6. Female subjects of childbearing potential must have a negative pregnancy test upon study entry
7. Female subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study
8. Children and families have desire to reintroduce potential food allergens and either the food antigen has been recommended with plans for its introduction as part of Standard of Care by the child's allergist and/or gastroenterologist OR the swallowed topical steroid therapy has been recommended to be discontinued by the child's allergist and/or gastroenterologist.
9. Children and families willing to undergo unsedated serial TNE

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. Bleeding disorder
3. Unwilling to undergo unsedated TNE
4. Unwilling or unable to come to hospital at least 3 times over 6 weeks.
5. Currently treated with a swallowed corticosteroid which is not being discontinued.
6. Treated with oral corticosteroids within 8 weeks of the start of the study.
7. More than one change is being made to the EoE treatment regimen (e.g., more than a single food is being reintroduced during the study period; the swallowed topical steroid is being discontinued at the same time a food is being introduced).
8. EoE has been symptomatic with clinically significant symptoms attributable to EoE including dysphagia, abdominal pain or vomiting in the period since endoscopy
9. The finding of uncontrolled cough, significant rhinorrhea or rhinitis obstructing nasal passages, oxygen saturations <92% (high altitude normal saturation), temperature >38 degrees Celsius, significant gastrointestinal illness within 1 week of TNE, or provider determination of significant illness during pre-procedure history and physical on the day that the TNE is planned.
10. Pregnancy, breast feeding or plans to become pregnant
11. Unable to complete study procedures including endoscopy.
12. Allergy to any material or medicine used for procedures
13. Use of investigational drugs within 16 weeks of participation
14. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment Phase; Treatment Phase will evaluate the effectiveness of Transnasal Esophagoscopy (TNE) as an acceptable form of monitoring Eosinophilic Esophagitis	Other: Transnasal esophagoscopy; single food antigen introduction OR removal of topical swallowed steroid therapy followed by surveillance utilizing TNE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological Improvement	To prospectively and serially evaluate the recurrence of esophageal eosinophilia (>15 eosinophils per high power field) after a clinical single food antigen introduction OR removal of swallowed topical steroid therapy by the subject's clinical allergist or gastroenterologist in children with EoE using unsedated Transnasal Endoscopy/Esophagoscopy.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic Appearances/Histological Findings	1. To identify serially the clinical (endoscopic appearances) and other histological findings (lamina propria fibrosis, mast cells, lymphocytes) associated with dietary food introductions OR swallowed topical steroid therapy removal in children with EoE.	6 weeks
Sample Size	2. To determine and evaluate mucosal sample size obtained during TNE (2.0 mm or 1.2 mm forceps) compared to that obtained during those same subjects' previous traditional sedated endoscopy/esophagoscopy (2.8 mm forceps).	6 weeks
Decision to participate	3. To assess family factors determining decision to complete TNE study and subject's satisfaction with serial TNE using the previously reported TNE Qualitative Questionnaire, the General Anxiety Disorder (GAD)-7 Anxiety Instrument and a structured interview.	6 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Center for Advancing Translational Sciences (NCATS); Office of Rare Diseases (ORD)
• Investigators: Principal Investigator: Joel Friedlander, M.D., Children's Hospital Colorado

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: 2017-0237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No