Cytosponge and Dietary Therapy in EoE

NCT02599558 | Completed Results FDA Device

• 1 other identifier: 15-004741
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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?

Conditions

Eosinophilic Esophagitis

Keywords

EOE

Outcome Measures

Primary Outcomes (1)

• Histological Remission by Sponge Cytology

  Number of subject's sponge cytology to accurately detect histological remission when compared with standard of care EGD (defined as a peak eosinophil count of \<15 eos/hpf on endoscopic biopsy)

  approximately 4 weeks post food reintroduction

Secondary Outcomes (1)

• Eosinophilic Esophagitis Activity Index Patient Reported Outcomes (EEsAI PRO) Score

  approximately 4 weeks post food reintroduction

Study Arms (1)

Cytosponge-directed food reintroduction

EXPERIMENTAL

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

Device: Cytosponge

Interventions

Cytosponge 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.

Also known as: sponge

Cytosponge-directed food reintroduction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 35697266 DERIVED

Related Links

• Mayo Clinic Clinical Trials
• Pub Med

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Jeffrey A. Alexander, M.D.
• Organization: Mayo Clinic

Alexander.Jeffrey14@mayo.edu

507+284-0474

Study Officials

• Jeffrey Alexander, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 6, 2015
• Study Start: November 1, 2015
• Primary Completion: January 8, 2022
• Study Completion: January 8, 2022
• Last Updated: December 30, 2022
• Results First Posted: December 30, 2022

Record last verified: 2022-12

Locations

US (1)