Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04149470
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2019-10-30
Brief Title:
Proton Pump Inhibitor PPI Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy TNE
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Proton Pump Inhibitor PPI Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy TNE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will enroll participants who have been diagnosed with Eosinophilic Esophagitis EoE Upon study enrollment the participant will begin a proton pump inhibitor PPI Omeprazole 20mg twice daily After taking Omeprazole for four weeks the participant will have a Transnasal Endoscopy and biopsies will be taken to determine the histological change If the biopsies are abnormal the participant continues Omeprazole and will undergo another endoscopy at eight weeks The study aims to determine the percentage of children with Eosinophilic Esophagitis who improve with PPI use and to determine the length of time and effectiveness of PPI therapy in the management of EoE The investigators hypothesize that following the initiation of PPI for treatment of Eosinophilic Esophagitis biopsies obtained will show decreasing eosinophil counts at four weeks which is sooner than the previously reported eight-week period
Detailed Description:
This study aims to learn more about the subset of children with Eosinophilic Esophagitis EoE who are on treatment with a proton pump inhibitor PPI EoE is an increasingly common allergic condition of the esophagus for which we have limited treatment options This study will be helpful in evaluating the minimal time frame required for histological improvement with the use of high dose PPI The study will enroll participants who have been diagnosed with Eosinophilic Esophagitis EoE and are recommended by their physician to begin PPI treatment with Omeprazole 20 mg twice daily After taking Omeprazole for four weeks the participant will undergo an unsedated Transnasal Endoscopy TNE in the outpatient clinic at Childrens Hospital Colorado TNE is a test in which the doctor inserts a skinny bendable tube with a camera through the nose to look directly into the esophagus the tube connecting the mouth to the stomach when you swallow and is an alternative method to assess esophageal mucosa without requiring general anesthesia Biopsies will be collected during the TNE to determine if there is histological change If the biopsies are normal the participant will complete the study If biopsies are abnormal and EoE is still active the participant will continue the Omeprazole and undergo the standard of care endoscopy at eight weeks The participant will choose the type of endoscopy- unsedated TNE or esophagogastroduodenoscopy EGD under anesthesia Participants will also complete surveys during study enrollment about medication compliance Eosinophilic Esophagitis symptoms anxiety TNE experience and undergo a physical exam The investigators hypothesize that following the initiation of PPI for treatment of Eosinophilic Esophagitis biopsies obtained will show decreasing eosinophil counts at four weeks which is sooner than the previously reported eight-week period Results from this study will be generalizable to the pediatric EoE population and the knowledge gained will provide key preliminary data to support clinical recommendations for pediatric EoE patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None