Tiny study tests if PPIs loosen a stiff esophagus
NCT ID NCT03312686
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study at Indiana University will test whether a 2-month course of high-dose proton pump inhibitors (PPIs) can improve the flexibility (distensibility) of the esophagus in 10 people with eosinophilic esophagitis (EoE). Researchers will measure flexibility in both the upper and lower esophagus before and after treatment, and see if changes relate to reduced inflammation. The goal is to better understand how treating inflammation affects swallowing function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- proton pump inhibitors (PPIs)
- What this could lead to
- If successful, this could show that treating inflammation with PPIs improves esophagus flexibility, potentially guiding better management of swallowing difficulties.
- What could go wrong
- This is a very small pilot study with only 10 participants, so results may not apply to everyone. It is designed to gather information, not to prove a treatment works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2016
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients presenting to the clinic and endoscopy who are undergoing endoscopy with endoflip
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Indiana University
RECRUITINGIndianapolis, Indiana, 46202, United States
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Indiana University Health University Hospital
RECRUITINGIndianapolis, Indiana, 46202, United States
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