Short Duration 6Fed Sponge For EoE Patients

NCT03354221 | Withdrawn FDA Device

• 1 other identifier: 17-002185
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eosinophilic Esophagitis

Keywords

EoE

Outcome Measures

Primary Outcomes (1)

• Cytosponge pathology: number of Eosinophils directing dietary therapy

  Patients will swallow the cytosponge at 2 weeks, 4 weeks and 6 weeks into the initial period of the 6 food elimination diet. Eosinophils \<15 phf will be considered histologic remission to dietary therapy. This response will be compared to the 6 week visit sponge eosinophilic histology.

  2 years

Secondary Outcomes (2)

• Eosinophilic Esophgitis Activity Index Pro (EEsAI Pro)

  2 years

• The tolerability of esophageal sponge compared to upper endoscopy with biopsy.

  6 weeks

Study Arms (1)

Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale

EXPERIMENTAL

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.

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

Interventions

Cytosponge DEVICE

Patients undergoing the six food elimination diet will be monitored during the initial elimination period at 2, 4 and 6 weeks with swallowing the cytosponge. This is a ten minute procedure in the office. The cytosponge will be sent to the lab for histology reading of the eosinophilic count.

Also known as: sponge

Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale

Diet OTHER

During the initial 6 week elimination period, participants will eliminate the 6 most common food allergens from their diet (fish, nuts, eggs, soy, wheat, dairy). Participants will return for the cytosponge during this time at 2, 4 and 6 weeks of elimination.

Also known as: SFED, 6FED

Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale

EEsAI Pro OTHER

This is a short questionnaire to assess the participants swallowing. This will be completed at baseline and during each cytosponge visit during the initial elimination period (2, 4, 6 weeks).

Also known as: Eosinophilic Esophagitis Activity Index Pro questionnaire

Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale

Likert Scoring Scale OTHER

This is a short questionnaire for patients to compare their experiences swallowing the cytosponge versus completing an upper endoscopy. The scale is rated from "worst experience" to "best experience."

Also known as: Likert score

Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (12)

• Aceves SS, Ackerman SJ. Relationships between eosinophilic inflammation, tissue remodeling, and fibrosis in eosinophilic esophagitis. Immunol Allergy Clin North Am. 2009 Feb;29(1):197-211, xiii-xiv. doi: 10.1016/j.iac.2008.10.003.

  PMID: 19141355 BACKGROUND

• Kelly KJ, Lazenby AJ, Rowe PC, Yardley JH, Perman JA, Sampson HA. Eosinophilic esophagitis attributed to gastroesophageal reflux: improvement with an amino acid-based formula. Gastroenterology. 1995 Nov;109(5):1503-12. doi: 10.1016/0016-5085(95)90637-1.

  PMID: 7557132 BACKGROUND

• Liacouras CA, Spergel JM, Ruchelli E, Verma R, Mascarenhas M, Semeao E, Flick J, Kelly J, Brown-Whitehorn T, Mamula P, Markowitz JE. Eosinophilic esophagitis: a 10-year experience in 381 children. Clin Gastroenterol Hepatol. 2005 Dec;3(12):1198-206. doi: 10.1016/s1542-3565(05)00885-2.

  PMID: 16361045 BACKGROUND

• Peterson KA, Byrne KR, Vinson LA, Ying J, Boynton KK, Fang JC, Gleich GJ, Adler DG, Clayton F. Elemental diet induces histologic response in adult eosinophilic esophagitis. Am J Gastroenterol. 2013 May;108(5):759-66. doi: 10.1038/ajg.2012.468. Epub 2013 Feb 5.

  PMID: 23381017 BACKGROUND

• Gonsalves N, Yang GY, Doerfler B, Ritz S, Ditto AM, Hirano I. Elimination diet effectively treats eosinophilic esophagitis in adults; food reintroduction identifies causative factors. Gastroenterology. 2012 Jun;142(7):1451-9.e1; quiz e14-5. doi: 10.1053/j.gastro.2012.03.001. Epub 2012 Mar 3.

  PMID: 22391333 BACKGROUND

• Lucendo AJ, Arias A, Gonzalez-Cervera J, Yague-Compadre JL, Guagnozzi D, Angueira T, Jimenez-Contreras S, Gonzalez-Castillo S, Rodriguez-Domingez B, De Rezende LC, Tenias JM. Empiric 6-food elimination diet induced and maintained prolonged remission in patients with adult eosinophilic esophagitis: a prospective study on the food cause of the disease. J Allergy Clin Immunol. 2013 Mar;131(3):797-804. doi: 10.1016/j.jaci.2012.12.664. Epub 2013 Jan 31.

  PMID: 23375693 BACKGROUND

• Kagalwalla AF, Shah A, Li BU, Sentongo TA, Ritz S, Manuel-Rubio M, Jacques K, Wang D, Melin-Aldana H, Nelson SP. Identification of specific foods responsible for inflammation in children with eosinophilic esophagitis successfully treated with empiric elimination diet. J Pediatr Gastroenterol Nutr. 2011 Aug;53(2):145-9. doi: 10.1097/MPG.0b013e31821cf503.

  PMID: 21788754 BACKGROUND

• Arias A, Gonzalez-Cervera J, Tenias JM, Lucendo AJ. Efficacy of dietary interventions for inducing histologic remission in patients with eosinophilic esophagitis: a systematic review and meta-analysis. Gastroenterology. 2014 Jun;146(7):1639-48. doi: 10.1053/j.gastro.2014.02.006. Epub 2014 Feb 15.

  PMID: 24534634 BACKGROUND

• Molina-Infante J, Arias A, Barrio J, Rodriguez-Sanchez J, Sanchez-Cazalilla M, Lucendo AJ. Four-food group elimination diet for adult eosinophilic esophagitis: A prospective multicenter study. J Allergy Clin Immunol. 2014 Nov;134(5):1093-9.e1. doi: 10.1016/j.jaci.2014.07.023. Epub 2014 Aug 28.

  PMID: 25174868 BACKGROUND

• Katzka DA, Geno DM, Ravi A, Smyrk TC, Lao-Sirieix P, Miremadi A, Debiram I, O'Donovan M, Kita H, Kephart GM, Kryzer LA, Camilleri M, Alexander JA, Fitzgerald RC. Accuracy, safety, and tolerability of tissue collection by Cytosponge vs endoscopy for evaluation of eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2015 Jan;13(1):77-83.e2. doi: 10.1016/j.cgh.2014.06.026. Epub 2014 Jul 3.

  PMID: 24997328 BACKGROUND

• Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693. doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9.

  PMID: 23567357 BACKGROUND

• Schoepfer AM, Straumann A, Panczak R, Coslovsky M, Kuehni CE, Maurer E, Haas NA, Romero Y, Hirano I, Alexander JA, Gonsalves N, Furuta GT, Dellon ES, Leung J, Collins MH, Bussmann C, Netzer P, Gupta SK, Aceves SS, Chehade M, Moawad FJ, Enders FT, Yost KJ, Taft TH, Kern E, Zwahlen M, Safroneeva E; International Eosinophilic Esophagitis Activity Index Study Group. Development and validation of a symptom-based activity index for adults with eosinophilic esophagitis. Gastroenterology. 2014 Dec;147(6):1255-66.e21. doi: 10.1053/j.gastro.2014.08.028. Epub 2014 Aug 23.

  PMID: 25160980 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Diet

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Karthik Ravi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: November 27, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: March 15, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (1)