Exploring esophageal distensibility changes with proton pump inhibitors in eosinophilic esophagitis
Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
This study is testing how well proton pump inhibitors can improve the flexibility of the esophagus in people with eosinophilic esophagitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT03312686 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the relationship between eosinophilic inflammation in the esophagus and its distensibility after treatment with proton pump inhibitors. It aims to measure the distensibility of both the proximal and distal esophagus using the EndoFlip technology, before and after treatment. The study focuses on patients with eosinophilic esophagitis, specifically looking at changes in esophageal function related to eosinophilia. By assessing distensibility across different segments of the esophagus, the study seeks to provide insights into the effects of treatment on esophageal health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with eosinophilia confirmed by esophageal biopsy.
Not a fit: Patients with secondary causes of eosinophilia, those under 18 or over 65, or individuals with contraindications for biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with eosinophilic esophagitis, enhancing their quality of life.
How similar studies have performed: While this approach is novel in measuring esophageal distensibility across multiple segments, previous studies have shown promise in understanding eosinophilic esophagitis treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Presence of eosinophilia on esophageal biopsy, defined as a peak count of \> 15 eosinophils per high power field (HPF) on light microscopy based on biopsies from at least 2 of the 3 biopsy segments (upper, middle and distal esophagus) Exclusion Criteria: 1. Secondary causes of esophageal eosinophilia has been excluded, such as eosinophilic GI diseases, celiac disease, Crohn's disease, esophageal infection, hypereosinophilic syndrome, drug hypersensitivity, vasculitis, pemphigus, connective tissue diseases, graft vs. host disease 2. Age \< 18 or \> 65 years 3. Contraindication for biopsy, such as presence of esophageal varices, coagulopathy 4. History of esophageal surgery, gastric or esophageal malignancy, anatomical abnormality, or major primary motility disorder (such as achalasia) 5. Pregnancy 6. Prisoners
Where this trial is running
Indianapolis, Indiana and 1 other locations
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Akiro Saito, MD — Indiana University
- Study coordinator: Maureen Schilling
- Email: maschi@iu.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.