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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Age < 18 or > 65 years

Contraindication for biopsy, such as presence of esophageal varices, coagulopathy

History of esophageal surgery, gastric or esophageal malignancy, anatomical abnormality, or major primary motility disorder (such as achalasia)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • endoflip

    Diagnostic test

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Eosinophilic Esophagitis patients1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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