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

June 4, 2026 updated by: Joshua Wechsler, Ann & Robert H Lurie Children's Hospital of Chicago
This study is to observe the efficacy of the four food elimination diet.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The goals of treatment in EoE, like for most other chronic disorders, include: 1) resolution of clinical symptoms, 2) maintenance of remission and prevention of disease relapse 3) prevention of complications such as fibrosis and strictures by maintaining histological remission 4) prevention of iatrogenic treatment related adverse reactions such as nutritional deficiencies as in dietary treatment and 5) maintenance of quality of life.

Current standard of care for the treatment of EoE include either pharmacologic modality with glucocorticosteroids (oral, or swallowed spray or slurry) or diet. Swallowed steroids are the more commonly utilized form of steroid treatment modality with histological remission rates of 50-80% of subjects. The potential drawbacks of steroid therapy include side effects such as opportunistic infections, potential suppression of the pituitary-adrenal axis with prolonged use and most important disease recurrence once the medication is discontinued.

The dietary approach is based on the hypothesis that food antigen(s) trigger eosinophilic inflammation and clinical and histological remission can be induced by identifying and excluding the causative food antigen(s). It is believed that eliminating causative food antigen(s) target the cause and thus induces long term remission. The current recommendation for treatment of EoE with diet are based on a number of retrospective and observational studies.

This prospective study eliminating the four most common (cow milk protein, wheat, egg, and soy) antigens, will primarily assess the histological response in a cohort of children and will attempt to validate the findings of the previously published retrospective study. In addition by the process of orderly and sequential reintroduction of the excluded solids the investigators will identify the different foods responsible for causing esophageal inflammation and thus disease. This study will also characterize patient demographics, symptoms and histologic changes associated with the four food elimination (4-FED) process.

Health outcomes in children and adolescents related to EoE primarily focus on symptoms and histology. This does not take into consideration the health related quality of life (HRQOL), which may be conceptualized to include physical health, mental health, social functioning, role functioning, and general health perceptions.10 HRQOL has been shown to affect patient satisfaction with and adherence to treatment, and therefore long term outcomes.

The PedsQLTM 4.0 is a, self-administered, non-preference based generic instrument. It consists of a 23-item core measure of global health-related quality of life (HRQOL). The tool includes scales of physical, emotional, social and school function and is validated for children age 2-18 years. Multiple studies have demonstrated the reliability, validity and responsiveness of this instrument in healthy children and in children with chronic diseases. Even more recently developed is the PedsQLTM Eosinophilic Esophagitis Module, a disease-specific tool that has demonstrated excellent feasibility, reliability and validity in EoE patients.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from patients evaluated at, referred to and followed at one of the participating centers. The investigator or designee will recruit participants during clinic visits or over the phone following their diagnosis of EoE and decision of treatment

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
4FED Group
EoE patients recruited to this observational study will be monitored for treatment response to 4FED and treatment responders will be monitored during food reintroduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the Four Food Elimination Diet
Time Frame: every 6-12 months, at standard of score endoscopies
Demonstrate the efficacy of the empiric 4-FED in inducing clinical and histological remission in children with EoE.
every 6-12 months, at standard of score endoscopies

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying food triggers
Time Frame: every 6-12 months, at standard of score endoscopies
Identify specific foods responsible for causing disease from those who successfully respond to the 4-FED.
every 6-12 months, at standard of score endoscopies
Allergy skin prick correlation
Time Frame: every 6-12 months, at standard of score endoscopies
Determine if allergy skin prick testing identifies the same foods responsible for causing esophageal inflammation as those identified based on food challenge and histology
every 6-12 months, at standard of score endoscopies
Determining most common and least common food trigger
Time Frame: every 6-12 months, at standard of score endoscopies
Determine if cow's milk protein is the most common food antigen and soy the least common food antigen causing esophageal inflammation once foods are reintroduced back into their diet.
every 6-12 months, at standard of score endoscopies
Food reintroduction Quality of Life measurement
Time Frame: every 6-12 months, at standard of score endoscopies
Determine how the 4-FED and the elimination and reintroduction of foods affects the quality of life of patients with EoE.
every 6-12 months, at standard of score endoscopies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Joshua B Wechsler, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-14635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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