Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371941
• Other study ID #: 13-02521-FB
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2023
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• oral cromolyn sodium
Oral cromolyn sodium
• Placebo
Saline

Locations

Country	Name	City	State
United States	LeBonheur Children's Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Esophageal Eosinophil Count	Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy	2 months
Secondary	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.	Baseline as compared to 2 months