Short Duration 6Fed Sponge For EoE Patients

January 22, 2020 updated by: Karthik Ravi, M.D., Mayo Clinic

A Pilot Study Assessing the Efficacy of Short Duration Six Food Elimination Diet in Eosinophilic Esophagitis (EoE)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale
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
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.
Other Names:
  • sponge
Other: Diet
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.
Other Names:
  • SFED, 6FED
Other: EEsAI Pro
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).
Other Names:
  • Eosinophilic Esophagitis Activity Index Pro questionnaire
Other: Likert Scoring Scale
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."
Other Names:
  • Likert score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytosponge pathology: number of Eosinophils directing dietary therapy
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eosinophilic Esophgitis Activity Index Pro (EEsAI Pro)
Time Frame: 2 years
The EEsAI Pro uses the VDQ is visual dysphagia question AMS is avoidance, modification, slow eating question. Thes two along with questions on frequency of, duration of, pain associated with dysphagia make up the PRO (patient reported outcomes). The PRO is a number (0-100) calculated from the answer to the questions. A PRO<20 defines asymptomatic EoE.
2 years
The tolerability of esophageal sponge compared to upper endoscopy with biopsy.
Time Frame: 6 weeks
Patients return at the end of the 6 weeks initial elimination of the diet will complete the modified Likert scoring scale. This scale rates participant experience of the cytosponge versus the upper endoscopy. 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."
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Karthik Ravi, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ACTUAL)

March 15, 2019

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (ACTUAL)

November 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-002185

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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