Actively Recruiting
Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
Led by Indiana University · Updated on 2025-11-24
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether treating eosinophilic inflammation in the esophagus improves how well the esophagus can stretch, known as esophageal distensibility. This pilot study focuses on patients with eosinophilic esophagitis (EoE), a condition where eosinophils affect the upper, middle, and lower parts of the esophagus. The study aims to measure esophageal distensibility both near the top (proximal) and bottom (distal) before and after treatment, as previous measurements focused only on the lower esophagus and esophagogastric junction. Participants will receive a two-month course of high-dose proton pump inhibitors (PPIs) to reduce eosinophilia in their esophagus. The study uses a diagnostic tool called EndoFlip to assess esophageal distensibility. The main intervention is PPI treatment, and the research team will measure changes in esophageal distensibility and eosinophil counts before and after the treatment period. During the study, patients will undergo biopsies from the upper, middle, and distal esophagus to confirm eosinophilia and monitor changes. The primary outcome is the change in esophageal distensibility after two months of treatment, and a secondary outcome is the change in eosinophil numbers. The study includes adults aged 18 to 65 years and excludes certain conditions or histories that could affect results. The total treatment and observation period is two months.
CONDITIONS
Brief Title
Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Age between 18 and 65 years
You will not qualify if you...
- Secondary causes of esophageal eosinophilia have 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
- Age below 18 or above 65 years
- Contraindication for biopsy, such as presence of esophageal varices or coagulopathy
- History of esophageal surgery, gastric or esophageal malignancy, anatomical abnormality, or major primary motility disorder such as achalasia
- Pregnancy
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo diagnostic testing including esophageal biopsy and measurement of esophageal distensibility before PPI treatment.
1 visit (in-person)
Duration - 2 months
Participants receive a 2-month course of high dose proton pump inhibitors (PPI) as part of their routine care with observation of changes in esophageal distensibility and eosinophilia.
Visits may vary with routine care
Duration - 1 day
Participants undergo repeat diagnostic testing to assess changes in esophageal distensibility and eosinophilia after PPI treatment.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
M
Maureen Schilling
L
Lainna Cohen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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