EoE Food Desensitization

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT02881372

Collaborator

(none)

Enrollment

Location

Arm

56.7

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis	Other: Oral food desensitization	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 8, 2018

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Peak eosinophil count on esophageal biopsy [5 months]
Remission of esophageal eosinophilia as defined by having <15 eosinophils per high power field on peak esophageal biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Known or suspected flare-inducing food trigger based upon supporting histological evidence.
Already undergoing a baseline EGD followed by food reintroduction and repeat EGD, as standard of care at the recommendation of the child's gastroenterologist.
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.
Assent by the patient's pediatric gastroenterologist for the patient's participation in the study.

Exclusion Criteria:

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.
Previous or current diagnosis of cancer or leukemia.
History of chemotherapy within the past 3 months.
History of esophageal stricture or food impaction.
History of anaphylaxis or other severe adverse reaction to the specific food trigger being tested.