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Short Duration 6Fed Sponge For EoE Patients

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ClinicalTrials.gov Identifier: NCT03354221
Recruitment Status : Withdrawn (Change in literature to suggest at least 6 weeks of initial elimination is necessary to see decrease in eosinophil count.)
First Posted : November 27, 2017
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Device: Cytosponge Other: Diet Other: EEsAI Pro Other: Likert Scoring Scale Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study Assessing the Efficacy of Short Duration Six Food Elimination Diet in Eosinophilic Esophagitis (EoE)
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : December 2018
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Likert score




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354221


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Karthik Ravi Mayo Clinic
Additional Information:
Publications:

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Responsible Party: Karthik Ravi, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03354221    
Other Study ID Numbers: 17-002185
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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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
Keywords provided by Karthik Ravi, M.D., Mayo Clinic:
EoE
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases