Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

Phase 4CompletedNCT02371941

University of Tennessee16 enrolled

Overview

This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when made into a viscous preparation for the treatment of eosinophilic esophagitis.

Eosinophilic esophagitis is an antigen-mediated allergic disease of the esophagus characterized by symptoms of gastrointestinal complaints and eosinophilic inflammation limited to the esophagus. Currently, first line therapeutic recommendations include swallowed, topical steroids or dietary therapy. While both work for the majority of patients, they both have limitations. The investigators are examining the use of oral cromolyn sodium as a treatment for this condition. This medication is a non-steroid that is already approved for other conditions. When taken orally, it is essentially not absorbed systemically, so side effects are minimal. There is only 1 brief, retrospective report of its use in this condition suggesting it does not work. However, from studying swallowed, topical steroids, it may require formulating the medication into a viscous preparation for it to work.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Eosinophilic Esophagitis

Interventions

oral cromolyn sodiumDRUG

Oral cromolyn sodium

PlaceboDRUG

Saline

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of eosinophilic esophagitis Exclusion Criteria: * Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period. * Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline). * Evidence of pathologic eosinophilia in other locations in the GI tract. * Participation in another research protocol * Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)

Locations (1)

LeBonheur Children's Hospital

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Peak Esophageal Eosinophil Count

Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy

Time frame: 2 months

Secondary Outcomes

Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score

Symptom scores will be measures at baseline, 1 month, and 2 months using a symptom scoring assessment tool known as the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS). The PEESS is a validated symptom score that is completed by the parent of the patient. It encompasses frequency and severity of EoE related symptoms over the past month. The minimum score = 0. The max score = 98 The higher the score/value, the more severe and/or frequent the symptoms and therefore a worse outcome.

Time frame: Baseline as compared to 2 months

Data from ClinicalTrials.gov

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