EoE Food Desensitization

Withdrawn before enrolling · Not applicable

Conditions studied: Eosinophilic Esophagitis

In brief

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.

Key facts

Study ID

NCT02881372

Run by

The University of Texas Health Science Center, Houston

People needed

0

Starts

2018-08-08

Expected to finish

2023-05-01

Last updated by the study team

2024-05-09

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.