A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis

Completed · Not applicable

Conditions studied: Eosinophilic Esophagitis

In brief

Prospective, pragmatic standard of care clinical trial comparing dietary therapies of standard dairy elimination diet alone (DED) to dairy elimination plus food additive elimination (FREE)

Key facts

Study ID

NCT03657771

Run by

Nemours Children's Clinic

People needed

22

Starts

2018-11-12

Expected to finish

2023-12-31

Last updated by the study team

2025-02-10

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• An Institutional Review Board (IRB) approved written Parental Permission form is signed and dated by the parent or legal representative/caregiver.
• If applicable, an Institutional Review Board (IRB) approved written Assent form is signed and dated by the participant.
• 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.
• The participant is >2 years to <18 years of age.
• The participant has isolated esophageal eosinophilia (>15 eos/hpf).
• The family has access to the internet to complete weekly surveys and to a telephone to complete weekly follow up calls.
• The biopsy used to diagnose eosinophilic esophagitis was taken no more than 12 weeks prior to the date of enrollment.

You may not qualify if…

• The participant has peripheral eosinophilia > 1,500 µL
• The participant has concomitant GI inflammatory conditions (e.g. celiac disease, inflammatory bowel disease).
• The participant has a history of upper GI tract surgery (e.g. fundoplication)
• Acid reflux by pH probe is suggested (*A pH probe is not required, but may be done as standard of care)
• The participant has severe developmental delay that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study.
• The participant has taken prednisone in the last 12 weeks, or has taken fluticasone or budesonide in the last 8 weeks.
• 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.
• The participant has a psychiatric condition that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study.
• The participant does not speak or read English fluently.
• The participant is currently taking a PPI (If discontinued, no washout required.)
• The participant is currently on or previously failed a dairy free diet for EoE.

Where it is running

• Nemours/Alfred I DuPont Hospital for Children — Wilmington, Delaware, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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