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

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) without swallowed steroid medication (to optimize
statistical chance of finding a trigger food for EoE), is in histological remission, and has
been recommended as part of Standard of Care to start a single new food introduction 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.

Inclusion Criteria:

1. Participant must be able to understand and provide informed consent/assent

2. Males and females ages 8-22 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

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 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

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 swallowed corticosteroids

6. Treated with oral corticosteroids within 8 weeks of the start of the study.

7. EoE has been symptomatic with clinically significant symptoms attributable to EoE
including dysphagia, abdominal pain or vomiting in the period since endoscopy

8. 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.

9. Pregnancy, breast feeding or plans to become pregnant

10. Unable to complete study procedures including endoscopy.

11. Allergy to any material or medicine used for procedures

12. Use of investigational drugs within 16 weeks of participation

13. 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.