Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 2 - 18 |
Updated: | 5/6/2018 |
Start Date: | December 2014 |
End Date: | December 2017 |
A Randomized, Double-blind, Placebo-controlled Study of the Use of 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.
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.
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.
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)
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