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Clinical Trials/ACTRN12623000604606
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.

Registry
who.int
Start Date
June 2, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
orthern Adelaide Local Health Network

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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