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Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)
NCT04149470 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Omeprazole 20mg BID
Study Locations (1)
Colorado
- Children's Hospital Colorado — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2024-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04149470
The ClinicalTrials.gov registry entry for NCT04149470 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 1 intervention — of which Omeprazole 20mg BID is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04149470 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04149470 about?
NCT04149470 is a clinical study titled "Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)". 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...
What is the current status of trial NCT04149470?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2020-10-07. Estimated completion is 2024-08.
What conditions does trial NCT04149470 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04149470?
The interventions under investigation include: Omeprazole 20mg BID (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04149470?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04149470 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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