N/A
N=22
Cytosponge and Dietary Therapy in EoE
Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT02599558 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Histological Remission by Sponge Cytology — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cytosponge (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histological Remission by Sponge Cytology |
13 | — |
| SECONDARY Eosinophilic Esophagitis Activity Index Patient Reported Outcomes (EEsAI PRO) Score |
16.5 | — |
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?
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02599558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.