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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.
 
ClinicalTrials.gov Identifier: NCT02599558
Recruitment Status : Recruiting
First Posted : November 6, 2015
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE November 2, 2015
First Posted Date  ICMJE November 6, 2015
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02599558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytosponge and Dietary Therapy in EoE
Official Title  ICMJE A Pilot Trial of Dietary Therapy Directed by the Esophageal Sponge in the Management of Eosinophilic Esophagitis.
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?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Device: Cytosponge
  • Other: Diet
  • Other: Phone call
  • Other: EEsAI Pro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02599558
Other Study ID Numbers  ICMJE 15-004741
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey A Alexander, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Alexander, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP