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Completed

NCT Number: NCT02371941

Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LeBonheur Children's Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

oral cromolyn sodium

Drug

Oral cromolyn sodium

Other names: Gastrocrom

Placebo

Drug

Saline

Primary outcomes

  1. Peak Esophageal Eosinophil Count

    Time frame: 2 months

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

Secondary outcomes

  1. Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score

    Time frame: Baseline as compared to 2 months

    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.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2015
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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