Step-down Therapy Evaluation of Pantoprazole in Eosinophilic Esophagitis (STEP-EoE): A randomised trial of Pantoprazole at 40mg orally once daily compared to 20mg orally once daily in patients with Eosinophilic esophagitis (EoE) who initially respond to Pantoprazole 40mg orally twice daily.
Step-down Therapy Evaluation of Pantoprazole in Eosinophilic Esophagitis (STEP-EoE): A randomised trial of Pantoprazole at 40mg orally once daily compared to 20mg orally once daily in patients with Eosinophilic esophagitis (EoE) who initially respond to 40mg orally twice daily.
Northern Adelaide Local Health Network
72 participants
Feb 1, 2026
Interventional
Conditions
Summary
Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition causing narrowing of the oesophagus, manifesting clinically as dysphagia and food bolus impaction (FBO).Proton pump inhibitors (PPI’s) are a mainstay in treatment of EoE, and have proven efficacy in inducing and maintaining remission according to systematic reviews and meta-analysis. Optimal total daily dose and dose frequency schedule of PPI is an under-researched area of immediate relevance to patient care and implications include convenience, cost and safety. In the context of a current knowledge gap for optimal dosing of pantoprazole for patients with EoE who have responded to routine dosing at 40mg orally twice daily, we propose a RCT of dose adjustment to 40mg tablet orally once daily compared to 20mg tablet orally once daily, with a formalised treatment protocol and the ascertainment of symptom scores (questionnaire), endoscopic appearance, and histological findings (biopsy). The results will have the potential to improve management in future.
Eligibility
Inclusion Criteria4
- Patients who meet all the following criteria
- Present with food bolus obstruction (FBO) or dysphagia
- Diagnosed with EoE according to endoscopy and biopsy showing >15 eosinophils per high power field in any one oesophageal location (peak count).
- Currently taking pantoprazole 40mg orally twice daily with a demonstrated complete response at endoscopy and oesophageal biopsy with <5 eosinophils per high power field (HPF)
Exclusion Criteria6
- Coexistent medical conditions that could cause oesophageal eosinophilia (e.g. primary hypereosinophilic syndrome, organ transplant recipient, connective tissue disorder, crohn’s diesase)
- Medications that could cause oesophageal eosinophilia (e.g. antiepileptic, clozapine)
- Medications that could suppress the immune system and decrease eosinophil count (e.g,systemic corticosteroids, immunusupressants such as methotrexate or azathioprine, biological agents such as anti – TNF)
- Usual residence is a forensic facility
- Intellectual disability
- Pregnancy
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Interventions
Patients who have been treated with the standard dose of Pantoprazole (40 mg tablet taken orally twice daily) and have achieved remission—defined as fewer than 5 eosinophils per high-power field (HPF)—will be eligible for recruitment into the study. Randomisation will take place at the baseline visit, with treatment commencing 48 hours after randomisation. Participants will receive Pantoprazole 40 mg tablet orally once daily for 12 weeks. After 12 weeks of treatment, participants will be reviewed by their treating gastroenterologist, including assessment of endoscopy and biopsy results. If their condition remains stable (fewer than 15 eosinophils per HPF), they will continue with the current dose. If their condition worsens (greater than 15 eosinophils per HPF), they will return to the standard dose. Participants may withdraw from the study at any time if they choose to do so. Participants will be asked to estimate their compliance with the treatment at the time of each of their clinical visits (initial clinic visit and prior to follow up endoscopy) using a Likert Score (visual rank 1-10). In this real-world intention to treat study, patients that describe poor compliance will still continue the study.
Locations(1)
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ACTRN12625001297415