Exploring esophageal distensibility changes with proton pump inhibitors in eosinophilic esophagitis
Official title: Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
Run by Indiana University · NCT03312686 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Status | Recruiting |
| Started | November 2016 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT03312686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 65 with eosinophilia confirmed by esophageal biopsy.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel in measuring esophageal distensibility across multiple segments, previous studies have shown promise in understanding eosinophilic esophagitis treatment outcomes.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Upadacitinib for Eosinophilic Esophagitis in adults not responding to standard therapy
This study tests whether upadacitinib, taken with topical corticosteroids, can reduce disease activity in adults with eosinophilic esophagitis who still have symptoms.
-
A registry for adults with esophageal movement and reflux problems.
This project will collect esophageal function tests (manometry, pH-impedance, FLIP) and clinical data from adults with reflux or swallowing symptoms to see if combining these results helps guide diagnosis and long-term care.
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Using a mucosal impedance device to help diagnose chronic esophageal problems
This test tries a mucosal impedance device during upper endoscopy to see if it helps diagnose people with chronic reflux (GERD) or eosinophilic esophagitis.
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Esophageal string test to screen for eosinophilic esophagitis in adults of African descent with swallowing problems
This study will test whether a 1-hour esophageal string test can detect eosinophilic esophagitis in adults born in Africa (or with African parents) who have trouble swallowing.
-
Improving management of eosinophilic esophagitis in children and adolescents
This study is trying to find better ways to manage eosinophilic esophagitis in kids and teens by using simple tests to avoid invasive procedures and improve their quality of life.
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How common FIRE is and what it looks like in children with eosinophilic esophagitis
This project will see how often and in what ways Food Induced Immediate Response of the Esophagus (FIRE) occurs in children aged 6–17 who have eosinophilic esophagitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.