EoE Food Desensitization

May 7, 2024 updated by: Tu Thanh Mai, The University of Texas Health Science Center, Houston

Safety and Feasibility of Oral Food Desensitization in Children With Eosinophilic Esophagitis

This is a single-center, prospective, pilot clinical trial in which children ages 3-17 years with eosinophilic esophagitis (EoE) who have a known food that triggers EoE flares receive oral desensitization with that specific food antigen, followed by reintroduction of that food into the diet. The purpose of this study is to investigate the safety and feasibility of oral desensitization in children with EoE so that, if determined to be safe, can be repeated on a larger scale to determine efficacy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Eosinophilic esophagitis (EoE) is a clinicopathologic disorder of the esophagus triggered by food and/or environmental allergens and is characterized by symptoms of esophageal dysfunction and eosinophilia of the esophagus. Current therapy is centered on controlling inflammation with steroids and/or food antigen avoidance. Such treatment options have significant side effects and reduce quality of life, especially in children. The purpose of the study is to discover a way for flare-provoking foods to be reintroduced into the child's diet without the need for medical therapy.

The study would involve children ages 3-17 years with biopsy-proven EoE who have a known flare-inducing food trigger. Following baseline blood work and esophagogastroduodenoscopy (EGD), the investigators will initiate oral desensitization treatment in which the child swallows a spray solution containing his or her specific food allergen extract in increasing concentrations twice daily for 4 months. The next phase of the study would involve reintroduction of the actual food for 4 weeks followed by repeat blood work and EGD. Success would be defined by having a peak eosinophil count <15 per high power field on the final esophageal biopsy.

Oral food desensitization has been well-studied in patients with food allergies but never in patients with pre-existing EoE. In those studies, the adverse events included mild reactions, such as watery eyes, rhinitis, sneezing, throat pruritus, transient erythema and abdominal pain. These reactions usually did not require stopping desensitization and were well controlled by antihistamines and steroids. Benefits include children having a less restricted diet and eliminating the need for steroid therapy. This study should yield valuable information regarding the management of EoE, thereby improving the current understanding of its pathogenesis.

Study Type

Interventional

Phase

  • Not Applicable

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
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center

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

5 months to 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pediatric patient, ages 3-17 years, with known diagnosis of EoE based upon esophageal biopsy demonstrating ≥15 eos/hpf and lack of symptomatic or histological response to PPI therapy and/or normal esophageal pH evaluation.
  2. Known or suspected flare-inducing food trigger based upon supporting histological evidence.
  3. Already undergoing a baseline EGD followed by food reintroduction and repeat EGD, as standard of care at the recommendation of the child's gastroenterologist.
  4. Signed informed consent for the subject's participation in the study provided by the parent/ legal guardian and child/adolescent assent for subjects 7-17 years.
  5. Assent by the patient's pediatric gastroenterologist for the patient's participation in the study.

Exclusion Criteria:

  1. Presence of other disorders associated with similar clinical, histological or endoscopic features, such as PPI-responsive esophageal eosinophilia, esophageal eosinophilia associated with gastroesophageal reflux disease (GERD), Crohn's disease, infectious esophagitis (i.e. herpes simplex virus or candida), drug-associated esophagitis, collagen vascular disease, hypereosinophilic syndrome and eosinophilic gastroenteritis.
  2. Previous or current diagnosis of cancer or leukemia.
  3. History of chemotherapy within the past 3 months.
  4. History of esophageal stricture or food impaction.
  5. History of anaphylaxis or other severe adverse reaction to the specific food trigger being tested.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral food desensitization
All of the children enrolled in the study will receive oral food desensitization with his or her specific EoE flare-inducing food antigen (e.g. cow's milk protein). The food antigen will be diluted in a 50% glycerin/water solution containing ascorbic acid (Vitamin C) to stabilize and preserve the solution. This oral spray will need to be administered twice a day, every day for a total of 4 months.
Other: Oral food desensitization
The child's specific food antigen will be diluted in a 50% glycerin/water solution containing ascorbic acid (Vitamin C). This oral spray solution will need to be administered twice a day, every day for a total of 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak eosinophil count on esophageal biopsy
Time Frame: 5 months
Remission of esophageal eosinophilia as defined by having <15 eosinophils per high power field on peak esophageal biopsy
5 months

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Study Director: Marc Rhoads, MD, University of Texas

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

Helpful Links

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)

August 8, 2018

Primary Completion (Estimated)

May 1, 2023

Study Completion (Estimated)

May 1, 2023

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimated)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-17-0391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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