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Cytosponge and Dietary Therapy in EoE

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Jeffrey A Alexander, Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02599558
First received: November 2, 2015
Last updated: August 14, 2017
Last verified: August 2017
  Purpose
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 Intervention
Eosinophilic Esophagitis Device: Cytosponge Other: Diet Other: Phone call Other: EEsAI Pro

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Jeffrey A Alexander, Mayo Clinic:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 20
Study Start Date: November 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02599558

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M. Geno, CCRP    507-538-0367    geno.debra@mayo.edu   
Contact: Katrina J Pierce    507-538-1361    pierce.katrina@mayo.edu   
Principal Investigator: Jeffrey A. Alexander, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M. Geno, CCRP    507-538-0367    geno.debra@mayo.edu   
Contact: Katrina J Pierce    507-538-1361    pierce.katrina@mayo.edu   
Principal Investigator: Jeffrey A. Alexander, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeffrey Alexander, MD Mayo Clinic
  More Information

Responsible Party: Jeffrey A Alexander, Prinicipal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02599558     History of Changes
Other Study ID Numbers: 15-004741
Study First Received: November 2, 2015
Last Updated: August 14, 2017

Keywords provided by Jeffrey A Alexander, Mayo Clinic:
EOE

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 19, 2017