Short Duration 6Fed Sponge For EoE Patients

Dietary therapy has been shown to be successful in the treatment of adult and pediatric
patients with eosinophilic esophagitis (EoE). Dietary studies were initially reported in
children, but the results appear to be similar in adult patients. Elemental diets are
successful in 70-95% of patients but are poorly tolerated.

The six food elimination diet (SFED) involves the elimination of the six most common food
allergens (i.e. milk, wheat, soy, eggs, nuts, and fish) for six weeks and has become the
mainstay of dietary therapy in EoE. A six week SFED has demonstrated excellent efficacy and
durability in both pediatric and adult EoE. However, compliance with the SFED for a total of
six weeks can be challenging for patients.

Previous studies have found the esophageal sponge to be an accurate technique of accessing
esophageal eosinophilia in EoE . The sponge is swallowed as a 12 mm capsule on a string. The
capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be
pulled out the mouth five minutes after ingestion. In previous studies, the procedure was
very well tolerated and all patients preferred the sponge to endoscopy. Therefore the sponge
is a well tolerated, inexpensive, very low risk procedure that would be an ideal option to
replace EGD esophageal sampling in the evaluation of dietary treatment of EoE.

Although initially described as a six week trial, it is possible that a shorter duration food
elimination diet of 2 or 4 weeks would have equal efficacy. This would have important
implications for patients as it would make the diet more tolerable.

Inclusion criteria:

- Adults ages 18-70 years of age

- Diagnosis of EoE, i.e. symptoms of esophageal dysfunction with histologic finding of
15 or more eosinophils per high power field on esophageal biopsy despite 8 weeks of
high dose proton pump inhibitor therapy.

- Scheduled to initiate a clinical SFED for treatment of EoE

Exclusion criteria:

- Clinical evidence of infectious process potentially contributing to dysphagia (e.g.
candidiasis, CMV, herpes)

- Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture,
web, ring, achalasia, esophageal neoplasm)

- Esophageal minimal diameter < 13 mm on structured barium esophagram

- Inability to read due to: Blindness, cognitive dysfunction, or English language
illiteracy

- Pregnant women