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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 1 Year - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Joshua Wechsler, MD
Principal Investigator Affiliation Ann & Robert H Lurie Children's Hospital of Chicago
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Active, not recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Additional Details

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.

Contact a Trial Team

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Chicago, Illinois



Ann & Robert H Lurie Childjren's Hospital of Chicago

Chicago, Illinois, 60611

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