Cytosponge and Dietary Therapy in EoE
Study Details
Study Description
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 |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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 Names:
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 Names:
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 Names:
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 Names:
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Outcome Measures
Primary Outcome Measures
- Cytosponge pathology: number of Eosinophils directing dietary therapy [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) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the PPI therapy
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Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk
Exclusion Criteria:
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Clinical evidence of infectious process potentially contributing to dysphagia ( candidiasis, CMV, herpes)
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Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
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Esophageal minimal diameter < 13 mm on structured barium esophagram
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Jeffrey Alexander, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 15-004741