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Proton Pump Inhibitor

Omeprazole for Eosinophilic Esophagitis

Phase 4
Recruiting
Led By Nathalie Nguyen, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to undergo unsedated transnasal endoscopy (TNE)
Weight >20kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will enroll people with Eosinophilic Esophagitis. They will take Omeprazole for 4 weeks, have an endoscopy, and if the biopsies are abnormal, they will take Omeprazole for 8 more weeks. The trial is to determine how well Omeprazole works for treating Eosinophilic Esophagitis.

Who is the study for?
This trial is for children and young adults aged 8-22 who have been diagnosed with Eosinophilic Esophagitis (EoE) within the last six months. Participants must weigh over 20kg, be able to swallow pills or take medication with apple sauce, and be willing to undergo a transnasal endoscopy without sedation. Those with bleeding disorders, recent steroid treatments, nasal passage issues, GI illnesses, pregnancy plans or allergies to PPIs cannot join.Check my eligibility
What is being tested?
The study tests if Omeprazole (a proton pump inhibitor), taken twice daily at a dose of 20mg for four weeks followed by an endoscopic biopsy can improve EoE symptoms in children. If initial biopsies are abnormal after four weeks of treatment, participants continue taking Omeprazole until another check-up at eight weeks.See study design
What are the potential side effects?
Omeprazole may cause side effects such as headaches, stomach pain, nausea or vomiting, diarrhea or constipation. Some people might experience more serious effects like severe allergic reactions but these are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to have a nose scope without sedation.
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I weigh more than 20kg.
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I am between the ages of 8 and 22.
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I can swallow pills or take them with apple sauce.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Histological Response Rate at eight weeks
Change in Histological Response Rate at four weeks
Histological Response at baseline
Secondary outcome measures
Eosinophilic Esophagitis Histology Scoring System (HSS) scores at eight weeks
Eosinophilic Esophagitis Histology Scoring System (HSS) scores at enrollment
Eosinophilic Esophagitis Histology Scoring System (HSS) scores at four weeks
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: OmeprazoleExperimental Treatment1 Intervention
Participants will receive high dose PPI therapy (Omeprazole 20mg twice daily) and will be evaluated for histological improvement.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,793 Total Patients Enrolled
7 Trials studying Eosinophilic Esophagitis
1,661 Patients Enrolled for Eosinophilic Esophagitis
Children's Hospital ColoradoOTHER
116 Previous Clinical Trials
5,132,525 Total Patients Enrolled
1 Trials studying Eosinophilic Esophagitis
21 Patients Enrolled for Eosinophilic Esophagitis
Nathalie Nguyen, MDPrincipal InvestigatorChildren's Hospital Colorado

Media Library

Omeprazole (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04149470 — Phase 4
Eosinophilic Esophagitis Research Study Groups: Omeprazole
Eosinophilic Esophagitis Clinical Trial 2023: Omeprazole Highlights & Side Effects. Trial Name: NCT04149470 — Phase 4
Omeprazole (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04149470 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the overarching objectives of this research endeavor?

"This 8 week trial will measure the Change in Histological Response Rate at four weeks as its primary outcome. Secondary outcomes include PEESS (Pediatric Eosinophilic Esophagitis Symptom Severity Module) scores, which are an assessment tool to gauge a patient's experience with symptoms of EoE over the past month; and two sets of HSS(Histology Scoring System) Scores - one taken prior to treatment and another after eight weeks post-treatment."

Answered by AI

What clinical conditions typically respond to a regimen of Omeprazole 20mg BID?

"Omeprazole 20mg BID is an effective solution for treating gastroesophageal reflux disease, heartburn and Zollinger-Ellison Syndrome."

Answered by AI

Are new participants currently being admitted to this trial?

"According to the records on clinicaltrials.gov, this trial is currently seeking participants and was first posted in October 7th 2020 before receiving its most recent update July 28th 2022."

Answered by AI

How many participants are engaged in this research study?

"Affirmatively, clinicaltrials.gov has documented that this trial is still inviting patients to join the study. It was initially made public on October 7th 2020 and last modified on July 28th 2022 , with 90 participants being sought from one site."

Answered by AI

Does my profile qualify me to be a participant in this research?

"To participate in this medical trial, participants must have eosinophilic esophagitis and be between 8 to 22 years old. The study is hoping to recruit a total of 90 patients."

Answered by AI

Has the Federal Drug Administration authorized Omeprazole 20mg BID?

"Omeprazole 20mg BID's safety is rated a 3 on our 1-3 scale. This drug has been approved by the FDA due to its advancement into Phase 4 trials."

Answered by AI

Have other clinical trials featured the administration of a 20mg dose of Omeprazole twice daily?

"Presently, 10 clinical trials are being held to assess the efficacy of Omeprazole 20mg BID. None of these studies have advanced beyond Phase 3. Most sites for this research are located in Portland, Oregon; however there exist 50 other institutions that conduct similar experiments with this medication."

Answered by AI

Does this clinical investigation admit participants aged above sixty?

"The age range for enrolment into this medical trial is 8 to 22 years old. There are 28 trials available for individuals under the legal age and 44 clinical studies accessible to those over retirement age."

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~6 spots leftby Aug 2024