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Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)

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ClinicalTrials.gov Identifier: NCT04149470
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : August 1, 2022
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Omeprazole 20mg BID Phase 4

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 Omperazole 20 mg twice daily. After taking Omeprazole for four weeks, the participant will undergo an unsedated Transnasal Endoscopy (TNE) in the outpatient clinic at Children's 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 Omperazole and undergo the standard of care endoscopy at eight weeks. The participant will chose 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024


Arm Intervention/treatment
Experimental: Omeprazole
Participants will receive high dose PPI therapy (Omeprazole 20mg twice daily) and will be evaluated for histological improvement.
Drug: Omeprazole 20mg BID
High dose PPI therapy (Omeprazole 20mg twice daily)




Primary Outcome Measures :
  1. Histological Response at baseline [ Time Frame: baseline ]
    The histological response will be based on pathologist's review of esophageal biopsies for pediatric participants with Eosinophilic Esophagitis (EoE). EoE diagnosis is identified if there are ≥ 15 eosinophils per high power field (hpf) in the esophagus.

  2. Change in Histological Response Rate at four weeks [ Time Frame: 4 weeks ]
    The histological response will be based on pathologist's review of esophageal biopsies for pediatric participants with Eosinophilic Esophagitis (EoE) who are prescribed a high dose proton pump inhibitor, Omeprazole 20 mg twice daily. Biopsies will be evaluated using the EoE histological scoring system. Response will be defined as the peak eosinophil count of < 15 eosinophils per high power field and normal will be defined at 0 eosinophils per high power field.

  3. Change in Histological Response Rate at eight weeks [ Time Frame: 8 weeks ]
    The histological response will be based on pathologist's review of esophageal biopsies for pediatric participants with Eosinophilic Esophagitis (EoE) who are prescribed a high dose proton pump inhibitor, Omeprazole 20 mg twice daily. Biopsies will be evaluated using the EoE histological scoring system. Response will be defined as the peak eosinophil count of < 15 eosinophils per high power field and normal will be defined at 0 eosinophils per high power field.


Secondary Outcome Measures :
  1. PEESS (Pediatric Eosinophilic Esophagitis Symptom Severity Module) scores at enrollment [ Time Frame: At enrollment ]
    The PEESS (Pediatric Eosinophilic Esophagitis (EoE) Symptom Scores) validated assessment tool will be completed by participant and parent at the enrollment visit. PEESS is a metric that seeks to capture EoE specific symptoms directly from children and their parents. Scores range from 0 (never) to 4 (almost always) and each question measures frequency and severity of EoE symptoms in the past month.

  2. PEESS (Pediatric Eosinophilic Esophagitis Symptom Severity Module) scores at four weeks [ Time Frame: 4 weeks ]
    The PEESS (Pediatric Eosinophilic Esophagitis (EoE) Symptom Scores) validated assessment tool will be completed by participant and parent after four weeks using Omeprazole 20mg twice daily. PEESS is a metric that seeks to capture EoE specific symptoms directly from children and their parents. Scores range from 0 (never) to 4 (almost always) and each question measures frequency and severity of EoE symptoms in the past month.

  3. PEESS (Pediatric Eosinophilic Esophagitis Symptom Severity Module) scores at eight weeks [ Time Frame: 8 weeks ]
    The PEESS (Pediatric Eosinophilic Esophagitis (EoE) Symptom Scores) validated assessment tool will be completed by participant and parent after eight weeks using Omeprazole 20mg twice daily. PEESS is a metric that seeks to capture EoE specific symptoms directly from children and their parents. Scores range from 0 (never) to 4 (almost always) and each question measures frequency and severity of EoE symptoms in the past month.

  4. Eosinophilic Esophagitis Histology Scoring System (HSS) scores at enrollment [ Time Frame: At enrollment ]
    The EoE HSS provides a method to objectively assess histology change in esophageal biopsies beyond eosinophil count. The HSS evaluates eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces (DIS), surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. The study pathologist will review the historical esophageal biopsies using the HSS.

  5. Eosinophilic Esophagitis Histology Scoring System (HSS) scores at four weeks [ Time Frame: 4 weeks ]
    The EoE HSS provides a method to objectively assess histology change in esophageal biopsies beyond eosinophil count. The HSS evaluates eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces (DIS), surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. The study pathologist will review the participant's esophageal biopsies collected after four weeks of Omeprazole 20mg twice daily using the HSS.

  6. Eosinophilic Esophagitis Histology Scoring System (HSS) scores at eight weeks [ Time Frame: 8 weeks ]
    The EoE HSS provides a method to objectively assess histology change in esophageal biopsies beyond eosinophil count. The HSS evaluates eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces (DIS), surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. The study pathologist will review the participant's esophageal biopsies collected after eight weeks of Omeprazole 20mg twice daily using the HSS.



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Ages Eligible for Study:   8 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Male or female, ages 8-22
  • Current diagnosis of Eosinophilic Esophagitis (≥ 15 eos/HPF) within the last 6 months
  • Able to swallow pills or open capsule to take medication with apple sauce
  • Weight >20kg
  • Willing to undergo unsedated transnasal endoscopy (TNE)

Exclusion Criteria:

  • Inability or unwillingness of participant to give written informed consent or comply with study protocol.
  • Have a known bleeding disorder
  • Current topical esophageal corticosteroid or systemic steroid treatment within past 8 weeks
  • No therapy with H2 therapy within the past 16 weeks
  • Planned or anticipated change in the diet during the study duration.
  • Planned or anticipated change in other corticosteroid medications
  • Uncontrolled cough, rhinorrhea, rhinitis obstructing nasal passages, GI illness or determination of significant illness at screening
  • Pregnancy, breast feeding or plans to become pregnant
  • Use of investigational drug within last 16 weeks
  • Allergy to any medications used for procedures
  • Allergy to PPI
  • Past or current medical problems or findings from physical exam or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study

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): NCT04149470


Contacts
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Contact: Meredith Levy, MA 720-777-5279 meredith.levy@childrenscolorado.org
Contact: Nathalie Nguyen, MD 720-777-5438 nathalie.nguyen@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital Colorado
Investigators
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Principal Investigator: Nathalie Nguyen, MD Children's Hospital Colorado
Publications of Results:
Dellon ES, Liacouras CA, Molina-Infante J, Furuta GT, Spergel JM, Zevit N, Spechler SJ, Attwood SE, Straumann A, Aceves SS, Alexander JA, Atkins D, Arva NC, Blanchard C, Bonis PA, Book WM, Capocelli KE, Chehade M, Cheng E, Collins MH, Davis CM, Dias JA, Di Lorenzo C, Dohil R, Dupont C, Falk GW, Ferreira CT, Fox A, Gonsalves NP, Gupta SK, Katzka DA, Kinoshita Y, Menard-Katcher C, Kodroff E, Metz DC, Miehlke S, Muir AB, Mukkada VA, Murch S, Nurko S, Ohtsuka Y, Orel R, Papadopoulou A, Peterson KA, Philpott H, Putnam PE, Richter JE, Rosen R, Rothenberg ME, Schoepfer A, Scott MM, Shah N, Sheikh J, Souza RF, Strobel MJ, Talley NJ, Vaezi MF, Vandenplas Y, Vieira MC, Walker MM, Wechsler JB, Wershil BK, Wen T, Yang GY, Hirano I, Bredenoord AJ. Updated International Consensus Diagnostic Criteria for Eosinophilic Esophagitis: Proceedings of the AGREE Conference. Gastroenterology. 2018 Oct;155(4):1022-1033.e10. doi: 10.1053/j.gastro.2018.07.009. Epub 2018 Sep 6. Review.

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04149470    
Other Study ID Numbers: 19-1119
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Colorado, Denver:
EoE
PPI
Proton Pump Inhibitor
Omeprazole
eosinophil
TNE
Transnasal Endoscopy
Esophageal Diseases
Esophagitis
Gastrointestinal Diseases
Eosinophilia
Gastroenteritis
Eosinophilic Oesophagitis
Transnasal Esophagogastroduodenoscopy
Transnasal Esophagoscopy
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action