RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-11
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03312686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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)
  1. 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. 2. Age \< 18 or \> 65 years
  3. 3. Contraindication for biopsy, such as presence of esophageal varices, coagulopathy
  4. 4. History of esophageal surgery, gastric or esophageal malignancy, anatomical abnormality, or major primary motility disorder (such as achalasia)
  5. 5. Pregnancy
  6. 6. Prisoners

Contacts and Locations

Study Contact

Maureen Schilling
CONTACT
maschi@iu.edu
Lainna Cohen
CONTACT
3172780621
larcohen@iu.edu

Principal Investigator

Akiro Saito, MD
PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine

Study Locations (Sites)

Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
Indiana University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Akiro Saito, MD, PRINCIPAL_INVESTIGATOR, Indiana University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-11
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2016-11
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • endoflip

Additional Relevant MeSH Terms

  • Eosinophilic Esophagitis