A Prospective Study of the Four Food Elimination Diet for Treatment of Eosinophilic Esophagitis

Running, not enrolling

Conditions studied: Eosinophilic Esophagitis

In brief

This study is to observe the efficacy of the four food elimination diet.

Key facts

Study ID

NCT05176262

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

64

Starts

2011-07-01

Expected to finish

2027-12-01

Last updated by the study team

2026-06-05

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ages 12 months-18 years
• Presence of clinical symptoms related to esophageal dysfunction such as: feeding aversion, failure to thrive, vomiting, abdominal pain, dysphagia, heartburn, and food impaction
• Histologic criteria for the diagnosis of EoE with ≥15 eosinophils per high power field from review of a total of six biopsies obtained from the distal and mid (three from each site) esophagus in subjects who were adequately pre-treated with a proton-pump inhibitor- 1mg/kg/dose twice daily, up to a maximum of 40mg or 30mg per dose depending on preparation for 6-8 weeks or had a normal 24 hour ph probe study18
• Patients who agree to 4-FED as their treatment of EoE

You may not qualify if…

• Those patients who are on oral or swallowed steroids (prior use of steroids that was discontinued more than two months prior to enrollment does not constitute an exclusion criterion)
• Patients who are unable to tolerate the 4-FED
• Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis

Where it is running

• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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