ACTRN12623000604606
Recruiting
Phase 4
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).
orthern Adelaide Local Health Network0 sites72 target enrollmentJune 2, 2023
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Eosinophilic oesophagitis (EoE)
- Sponsor
- orthern Adelaide Local Health Network
- Enrollment
- 72
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Exclusion criteria will comprise any of the following conditions or factors:
- •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
Outcomes
Primary Outcomes
Not specified
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