Short Duration 6Fed Sponge For EoE Patients

Mayo Clinic

Status: Withdrawn

Conditions: Eosinophilic Esophagitis

Treatments: Other: Likert Scoring Scale; Other: EEsAI Pro; Device: Cytosponge; Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03354221

17-002185

Details and patient eligibility

About

This research is being done to see if the investigators can use the cytosponge or esophacap (depending on availability) to determine if shorter duration SFED (two weeks versus six weeks) would have equal results.

Full description

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale

Experimental group

Description:

Patients going through the six food elimination diet (clinically) for EoE will be asked to participate. During the initial 6 week elimination period, participants will return at 2, 4 and 6 weeks to swallow the cytosponge. The cytosponge is a 10 minute procedure done in the office. This will be sent for histology, \<15 phf would be considered a responder. Results of the histology will help the investigator to direct the future of the 6 food elimination diet to determine if a period of 6 weeks of initial elimination is necessary. The EEsAI Pro questionnaire measures symptomatic response to the elimination of the foods. The Likert Scoring Scale measures patient experience of the cytosponge and the upper endoscopy.

Treatment:

Other: Diet

Other: EEsAI Pro

Device: Cytosponge

Other: Likert Scoring Scale