RecruitingPhase 4ACTRN12623000604606

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).


Sponsor

Northern Adelaide Local Health Network

Enrollment

72 participants

Start Date

Dec 20, 2023

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition of the oesophagus (food pipe) where immune cells called eosinophils build up, causing the oesophagus to narrow. This leads to difficulty swallowing and episodes where food gets stuck. Two main types of medication are used first-line: proton pump inhibitors (PPIs, such as pantoprazole) and topical corticosteroids (TCs, such as Jorveza). Both have evidence behind them, but it is unclear which works better. This study is a randomised controlled trial directly comparing PPI versus topical corticosteroids in adults with EoE, using detailed symptom questionnaires, endoscopy results, biopsy findings, and oesophageal pressure measurements to see which treatment is superior. You may be eligible if you are 18 or older, have been diagnosed with EoE (confirmed by biopsy showing elevated eosinophils), and presented with food bolus obstruction or swallowing difficulties. You may need to stop current EoE treatment for 8 weeks before joining. People with other causes of oesophageal eosinophilia, intellectual disabilities, or who are pregnant would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 exten

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)

SA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12623000604606