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Cytosponge and Dietary Therapy in EoE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02599558
Recruitment Status : Recruiting
First Posted : November 6, 2015
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic

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?

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Device: Cytosponge Other: Diet Other: Phone call Other: EEsAI Pro Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Trial of Dietary Therapy Directed by the Esophageal Sponge in the Management of Eosinophilic Esophagitis.
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cytosponge,Diet,EEsAI Pro,Phone call
Patients going through the six food elimination diet (clinically)for EoE, will be asked to participate. We will introduce 1 of the 6 foods previously eliminated for two weeks, than another for two weeks, at the end of 4 weeks the participant will return to swallow the cytosponge to monitor them through the diet, rather than multiple repeat Upper Endoscopies. 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 diet, which foods to add or take out of the diet.
Device: Cytosponge
Patients undergoing the six food elimination diet will be monitored through the diet 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
Investigators will reintroduce 1 of the six food for two weeks, then another for two weeks. Participant will return for the cytosponge procedure which will help the Investigator to direct which foods will be add or removed for the next two to four weeks. This will be repeated until all six foods have been reintroduced back into the participants diet.
Other Name: SFED

Other: Phone call
The study coordinator will call the participant two weeks after the participate has added in one of the six foods as directed by the Investigator, completing a short questionnaire (esophageal eosinophilic Activity Index Pro) EEsAI Pro.
Other Name: follow up

Other: EEsAI Pro
This is a short questionnaire to assess the participants swallowing. This will be completed at baseline, two weeks after a food has been added to the diet and at the final visit.
Other Name: Eosinophilic Esophagitis Activity Index Pro questionnaire

Primary Outcome Measures :
  1. Cytosponge pathology: number of Eosinophils directing dietary therapy [ Time Frame: 2 years ]
    Patients will swallow the cytosponge after adding foods back into their diet as directed by the physician. Eosinophils <15 phf will be considered histologic remission to dietary therapy.

Secondary Outcome Measures :
  1. Eosinophilic Esophagitis 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 . These 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

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

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

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 identifier (NCT number): NCT02599558

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M. Geno, CCRP    507-538-0367   
Contact: Crystal J Lavey, CRC    507-538-1361   
Principal Investigator: Jeffrey A. Alexander, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M. Geno, CCRP    507-538-0367   
Contact: Katrina J Pierce    507-538-1361   
Principal Investigator: Jeffrey A. Alexander, M.D.         
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Jeffrey Alexander, MD Mayo Clinic
Additional Information:
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Responsible Party: Jeffrey A Alexander, Prinicipal Investigator, Mayo Clinic Identifier: NCT02599558    
Other Study ID Numbers: 15-004741
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Jeffrey A Alexander, Mayo Clinic:
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases