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Trial record 3 of 6 for:    17919504 [PUBMED-IDS]

EoE Food Desensitization

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ClinicalTrials.gov Identifier: NCT02881372
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Cristoniel Santos Abrenica, The University of Texas Health Science Center, Houston

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 5 participants
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 : August 8, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881372


Contacts
Contact: Cristoniel S Abrenica, MD 713-500-5663 Cristoniel.S.Abrenica@uth.tmc.edu

Locations
United States, Texas
University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Cristoniel S Abrenica, MD    713-500-5663    Cristoniel.S.Abrenica@uth.tmc.edu   
Principal Investigator: Cristoniel S Abrenica, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Study Director: Marc Rhoads, MD University of Texas

Additional Information:
Publications:

Responsible Party: Cristoniel Santos Abrenica, Principal Investigator, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02881372     History of Changes
Other Study ID Numbers: HSC-MS-17-0391
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cristoniel Santos Abrenica, The University of Texas Health Science Center, Houston:
oral food desensitization
food elimination
food reintroduction

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases