Cytosponge and Dietary Therapy in EoE



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:1/9/2019
Start Date:November 2015
End Date:August 2020

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A Pilot Trial of Dietary Therapy Directed by the Esophageal Sponge in the Management of Eosinophilic Esophagitis.

This study is being done to see if the investigators can use only the cytosponge ( A 10
minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies
routinely perform during dietary restriction and food reintroduction in EoE?

Dietary Therapy has been shown to be successful in the treatment of adult and pediatric
patients with eosinophilic esophagitis 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. A six food elimination diet has been effective
in about 70% of adult patients with EoE . In these adult studies skin prick testing was not
helpful in predicting which foods would lead to a flare of disease when reintroduced into the
diet. Therefore, the current standard of care requires multiple EGDs with esophageal biopsy
during the dietary restriction and reintroduction phases of this study. Since the
investigators are making lifelong dietary decisions during this process of food
reintroduction, it is imperative the investigators be accurate. Unfortunately, these multiple
EGDs have significant cost and are invasive procedures with some risk. Moreover, there is
significant indirect costs with travel and time off work for the patients and drivers.
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.

Inclusion Criteria:

- Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the
PPI therapy

- Going through the six food elimination diet or have just completed elimination the six
foods: fish, nuts, eggs, soy, wheat, and milk

Exclusion Criteria:

- Clinical evidence of infectious process potentially contributing to dysphagia (
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
We found this trial at
2
sites
Rochester, Minnesota 55905
Principal Investigator: Jeffrey A. Alexander, M.D.
Phone: 507-538-0367
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Jeffrey A. Alexander, MD
Phone: 507-538-0367
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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