Clinical trial Recruiting at 2 sites Observational Ages 18 to 65

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 typeObservational
Ages18 Years to 65 Years
SexAll
Enrollment10 (estimated)
SponsorIndiana University
Academic / other
Locations2 sites (Indianapolis, Indiana and 1 other locations)
StatusRecruiting
StartedNovember 2016
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedNovember 24, 2025
Trial IDNCT03312686 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.