Cytosponge and Dietary Therapy in EoE

NCT ID: NCT02599558

Last Updated: 2022-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2022-01-08

Brief Summary

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?

Detailed Description

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.

Conditions

Eosinophilic Esophagitis

Keywords

EOE

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cytosponge-directed food reintroduction

Subjects will follow the six-food elimination diet per clinical protocol. The cytosponge will be used to monitor the diet at certain timepoints during food reintroduction

Group Type: EXPERIMENTAL

Cytosponge

Intervention Type: DEVICE

A capsule with a string attached with a sponge inside is swallowed. The string is held without any tension to allow the capsule to move into the stomach. The string will be held for five minutes to allow the capsule to dissolve in the stomach; a round mesh sponge about the size of a quarter is released.

Interventions

Cytosponge

A capsule with a string attached with a sponge inside is swallowed. The string is held without any tension to allow the capsule to move into the stomach. The string will be held for five minutes to allow the capsule to dissolve in the stomach; a round mesh sponge about the size of a quarter is released.

Intervention Type: DEVICE

Other Intervention Names

sponge

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey A Alexander

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Alexander, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

Alexander JA, Ravi K, Symrk TC, Wu TT, Lavey CJ, Geno D, Johnson AJ, Lennon RJ, Collins MH, Dellon ES, Katzka DA. Use of the Esophageal Sponge in Directing Food Reintroduction in Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):299-306.e3. doi: 10.1016/j.cgh.2022.05.029. Epub 2022 Jun 10.

Reference Type: DERIVED

PMID: 35697266 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

https://pubmed.ncbi.nlm.nih.gov/35697266/

Pub Med

Other Identifiers

15-004741

Identifier Type: -

Identifier Source: org_study_id