A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis

Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder of the esophagus. Primary
symptoms manifest while eating and include dysphagia, chest pain, and food impaction. EoE was
first described in the 1990s, but is increasingly recognized worldwide. It affects both
adults and children.

Given that EoE is thought to be an allergen driven disease, elimination diets are considered
logical and safe first-line treatment options. Elimination diets focus on the removal of the
food groups most likely to evoke the inflammatory response (e.g. dairy, wheat, soy, egg,
etc.). This is the first study to examine the effects of an additive free diet on
eosinophilic esophagitis.

Primary Objective: To compare histologic outcomes (eosinophils per high power field: eos/hpf)
of DED and FREE in children with eosinophilic esophagitis.

Secondary Objective: To compare endoscopic outcomes (Eosinophilic Esophagitis Endoscopic
Reference scores: EREFs) of DED and FREE in children with eosinophilic esophagitis

Tertiary Objectives: To compare symptomatic (Pediatric Eosinophilic Esophagitis Symptom
Severity Module v2.0: PEESS) and quality of life (Peds-QL EoE Module 1) outcomes of DED and
FREE in children with eosinophilic esophagitis

The investigators plan to enroll 72 patients over 4 sites each enrolling 18 patients per site
in a 16-month period (approximately 1 patient per month per site) having 9 patients per site
in each group (DED and FREE).

The investigators will enroll patients > 5- <17 years of age with isolated esophageal
eosinophilia (>15 eos/hpf). Patients with food impaction, peripheral eosinophilia > 1,500 µL
, concomitant GI inflammatory conditions, history of upper GI tract surgery (e.g.
fundoplication), acid reflux by pH probe, anaphylactic food allergies, severe developmental
delay, taking recently prescribed inhaled corticosteroids or oral corticosteroids, have other
medical conditions likely interfere with the study, has a significant psychiatric condition,
has taken a PPI in the last 4 weeks, has taken swallowed steroids in the last 12 weeks, or
are not fluent in spoken and written English will be excluded.

Participants will be enrolled at: Nemours Children's Hospital, Orlando, FL; Alfred I Dupont
Hospital, Wilmington, DE; Seattle Children's Hospital, Seattle, WA

Once eligibility criteria are met, participants will be randomized to DED or FREE study
groups. Participants will receive dietary education. Lead dietitians from each site will be
identified and the approaches to dietary education will be standardized. Dietary education
will be completed at the baseline visit and during follow up phone calls throughout the
study.Each participant will complete all study visits in 12 weeks.

Inclusion Criteria:

1. An Institutional Review Board (IRB) approved written Parental Permission form is
signed and dated by the parent or legal representative/caregiver.

2. If applicable, an Institutional Review Board (IRB) approved written Assent form is
signed and dated by the participant.

3. The participant/parent(s) or legal representative(s)/caregiver(s) are considered
reliable and capable of adhering to the protocol call schedule and dietary
requirements.

4. The participant is >5 years to <17 years of age.

5. The participant has isolated esophageal eosinophilia (>15 eos/hpf).

6. The family has access to the internet to complete weekly surveys and to a telephone to
complete weekly follow up calls.

7. The biopsy used to diagnose eosinophilic esophagitis was taken no more than 8 weeks
prior to the date of enrollment.

Exclusion Criteria:

1. The participant has food impaction.

2. The participant has peripheral eosinophilia > 1,500 µL

3. The participant has concomitant GI inflammatory conditions (e.g. celiac disease,
inflammatory bowel disease).

4. The participant has a history of upper GI tract surgery (e.g. fundoplication)

5. Acid reflux by pH probe is suggested (*A pH probe is not required, but may be done as
standard of care)

6. The participant has anaphylactic food allergies.

7. The participant has severe developmental delay that, in the opinion of the
investigator, could jeopardize the participant's ability to participate in the study.

8. The participant is taking inhaled corticosteroids or oral corticosteroids for asthma,
or has taken them in the last two months.

9. The participant has other significant medical conditions that, in the opinion of the
provider, would impact the participant's ability to participate in the study.

10. The participant has a psychiatric condition that, in the opinion of the investigator,
could jeopardize the participant's ability to participate in the study.

11. The participant does not speak or read English fluently.

12. The participant has taken a PPI in the last 4 weeks.

13. The participant has taken a swallowed steroid in the last 12 weeks.