ClinicalTrials.gg
RecruitingNCT03312686EOEUpdated Nov 24, 2025

Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study

An observational study in Eosinophilic Esophagitis, sponsored by Indiana University. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Indiana University · Observational

From the registry’s dates

  • Started Nov 2016; still recruiting 10 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 165 studies in Eosinophilic Esophagitis with a site in United States — 23 open to participants now, 41 under way, 3 of them phase 3. Eosinophilic Esophagitis · United States.

Planned enrollment
50th of 53
10 · median 80
Started
2016
with 8 others
Observational
53 of 165
13 open now
Primary completion
2026-12
later than 20 of 40 live
Registered
85th of 165
by date

Among the 165 studies in Eosinophilic Esophagitis with a site in United States, this one is the 50th largest by planned enrollment of the 53 observational ones that give a count, is one of 9 that started in 2016, is one of 53 observational ones, reaches primary completion later than 20 of the 40 other live ones, and was the 85th registered.

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

Browse Eosinophilic Esophagitis studies →

Open to participants now

23 of the 165 studies in Eosinophilic Esophagitis with a site in United States are open now. Recruiting first, the newest first:

17 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study summary

This pilot study will explore whether treatment of eosinophilic inflammation in the esophagus is associated with an improved distensibility of the esophagus. Furthermore, previous studies of the esophagus using EndoFlip only measured distensibility of the distal esophagus, specifically the distal esophagus and esophagogastric junction. Eosinophilia in EoE has been demonstrated to affect both upper, middle and lower esophagus. The aim is to measure distensibility both proximal and distal, before and after treatment.

03

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • endoflip
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting to the clinic and endoscopy who are undergoing endoscopy with endoflip

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1. Presence of eosinophilia on esophageal , 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

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 , vasculitis, pemphigus, connective tissue diseases, graft vs. host disease
  2. Age \< 18 or > 65 years
  3. for , such as presence of esophageal varices, coagulopathy
  4. History of esophageal surgery, gastric or esophageal , anatomical abnormality, or major primary motility disorder (such as achalasia)
  5. Pregnancy
  6. Prisoners
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • Eosinophilic Esophagitis patients

    PPI treatment

    Diagnostic Test: endoflip

Interventions

  • Diagnostic testendoflip

    Resolution of esophageal eosinophilia by a 2-month course of high dose PPI in patients will lead to improvement in esophageal distensibility, and thus should produce improvement in dysphagia symptoms.

06

What researchers measure

Primary outcomes

  1. Change in Esophageal Distensibility before and after treatment

    1\. Measure the changes in esophageal distensibility before and after treatment with PPI in patients with esophageal eosinophilia

    Time frame: 2 months

Secondary outcomes

  1. Change in eosinophilia or the number of eosinophils

    4\. To correlate changes of esophageal mucosa eosinophilia with changes of lumen distensibility in the different segments of the esophagus

    Time frame: 2 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2016 (actual). Primary completion is estimated for Dec 2026, 121 months after the start.

Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's planned 121 months is above that.

Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2017
First posted
Oct 18, 2017
StartActual
Nov 2016
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Nov 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03312686
Lead sponsor
Indiana University
Responsible party
Akira Saito (Assistant Professor of Clinical Medicine, Indiana University) — Principal investigator
First posted
Oct 18, 2017
Start date
Nov 2016
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 24, 2025

Study contacts

Maureen Schilling
Contact
maschi@iu.edu
Lainna Cohen
Contact
larcohen@iu.edu
3172780621
Akiro Saito, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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