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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT04149470
• Date of registration: 30/10/2019
• Prospective Registration: Yes
• Primary sponsor: University of Colorado, Denver
• Public title: Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)
• Scientific title: Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)
• Date of first enrolment: October 7, 2020
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04149470
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Rachel Andrews

• Name: Nathalie Nguyen, MD
• Affiliation: Children's Hospital Colorado

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: 22 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Omeprazole 20mg BID

Primary Outcome(s)

Change in Histological Response Rate at eight weeks [Time Frame: 8 weeks]

Change in Histological Response Rate at four weeks [Time Frame: 4 weeks]

Histological Response at baseline [Time Frame: baseline]

Secondary Outcome(s)

PEESS (Pediatric Eosinophilic Esophagitis Symptom Severity Module) scores at enrollment [Time Frame: At enrollment]

Eosinophilic Esophagitis Histology Scoring System (HSS) scores at four weeks [Time Frame: 4 weeks]

Eosinophilic Esophagitis Histology Scoring System (HSS) scores at enrollment [Time Frame: At enrollment]

PEESS (Pediatric Eosinophilic Esophagitis Symptom Severity Module) scores at eight weeks [Time Frame: 8 weeks]

Eosinophilic Esophagitis Histology Scoring System (HSS) scores at eight weeks [Time Frame: 8 weeks]

PEESS (Pediatric Eosinophilic Esophagitis Symptom Severity Module) scores at four weeks [Time Frame: 4 weeks]

Secondary ID(s)

19-1119

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's Hospital Colorado