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

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ClinicalTrials.gov Identifier: NCT03312686
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
John M. Wo, Indiana University

Brief 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.

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Diagnostic Test: endoflip

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Group/Cohort Intervention/treatment
Eosinophilic Esophagitis patients
PPI treatment
Diagnostic Test: endoflip
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.




Primary Outcome Measures :
  1. Change in Esophageal Distensibility before and after treatment [ Time Frame: 2 months ]
    1. Measure the changes in esophageal distensibility before and after treatment with PPI in patients with esophageal eosinophilia


Secondary Outcome Measures :
  1. Change in eosinophilia or the number of eosinophils [ Time Frame: 2 months ]
    4. To correlate changes of esophageal mucosa eosinophilia with changes of lumen distensibility in the different segments of the esophagus



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312686


Contacts
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Contact: Anita Gupta, MBBS 3179489227 anigupta@iu.edu
Contact: Basil Kahwash, MD 3179484272 bkahwash@iu.edu

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Responsible Party: John M. Wo, Director of Motility and Neurogastroenterology, Indiana University
ClinicalTrials.gov Identifier: NCT03312686    
Other Study ID Numbers: EOE-endoflip
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John M. Wo, Indiana University:
endoflip
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Eosinophilia
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases