Randomized head-to-head trial of proton pump inhibitor (PPI) vs topical corticosteroids (TCs) post food bolus impaction and/or for untreated patients with Eosinophilic esophagitis (EoE).
Northern Adelaide Local Health Network
72 participants
Dec 20, 2023
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). Two first line medications, namely proton pump inhibitors (PPI’s) and topical corticosteroids (TC’s) are feasible options. we propose an opened label, randomized controlled trial of PPI (Pantoprazole) vs TCs(Jorveza), with a formalized treatment protocol and the ascertainment of symptom scores (questionnaire), endoscopic appearance, histological findings (biopsy), physiological (manometry) and cross sectional (endoscopic ultrasound) data to determine if PPI or Jorveza are superior treatment.
Eligibility
Inclusion Criteria3
- Patients who present with a food bolus obstruction (FBO) or dysphagia.
- Diagnosed with EoE, which is defined as eosophageal biopsy containing >15 eosinophils per high power field, in any one oesophageal location (peak count).
- On nil current treatment, or willing to cease treatment with PPI or diet for 8 weeks prior to repeat endoscopy.
Exclusion Criteria6
- Coexistent medical conditions that could cause oesophageal eosinophilia (e.g. primary hypereosinophilic syndrome, organ transplant recipient, connective tissue disorder, Crohn’s disease)
- 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, immunosuppressant 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
Randomisation assessment will occur as baseline visit. The treatment commences 48 hours after randomization day. Pantoprazole 40mg oral tablet twice per day for 8 weeks, followed by a possible extension period of another 8 weeks. Following 8 weeks of treatment, participants will be reviewed by their treating gastroenterologist (with the first biopsy results). If the severity of their condition has not improved at 8 weeks (determined by >15 eosinophils per high power field [HPF]), participants will be switched to the other arm (Jorveza). The switching process is following study protocol, not participant’s choice. Participant can discontinue trial participation if they wish to.
Locations(1)
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ACTRN12623000604606