Effects of diet and omeprazole in patients with eosinophilic oesophagitis – a multi-centre, randomised controlled trial and investigation of novel disease mechanisms

Phase 3

Recruiting

• Conditions: Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; eosinophilic oesophagitis

• Registration Number: ACTRN12613001210763
• Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Stage 1: All patients with possible EOE (age 1-18 yrs) undergoing a diagnostic gastroscopy at any of the four participating hospitals (at Royal Children’s Hospital Melbourne, Monash Medical Centre Melbourne, Children’s Hospital at Westmead Sydney, and Women’s and Children’s Hospital Adelaide) will be assessed for inclusion in the study.
Patients undergoing a diagnostic gastroscopy will be assessed for upper gastrointestinal symptoms, including:
* Nausea and vomiting
* Abdominal pain
* Diarrhoea
* FFT/weight loss
* Dysphagia
* Regurgitation
* Food bolus obstruction
* Food refusal
Stage 2: Patients will be inclucded in the randomised trial if a diagnosis of EOE was confirmed based on biopsies from the first gastroscopy. Biospies will be analysed by the hospital’s anatomical pathologist to assess whether the diagnostic criteria for EOE is confirmed. The diagnosis of EOE is based on the presence of at least 20 mucosal eosinophils/HPF in any of the upper or lower oesophageal biopsies.
NB: Patients who are already avoiding a food prior to the study as part of a known food allergy (e.g. egg or peanut allergy) can still be considered for the study if EOE was diagnosed while avoiding the food (which suggests that the food is not causing the EOE).

Exclusion Criteria

Participants meeting the following criteria will be excluded from the study.
*The patient does not fulfil the histological criteria for EOE (less than 20 mucosal eosinophils/HPF on histology).
* Recent treatment with systemic corticosteroids (prednisolone) or topical or inhaled corticosteroids (fluticasone aerosol or viscous budesonide) within 3 months of the gastroscopy.
* Recent or current treatment with omeprazole.
* Patient already on multiple food elimination diet
* Previous failure of elimination diets (as it may skew the data towards non-response)
* Inability to obtain informed consent
* Inability to comply with the prescribed four-food elimination diet or PPI treatment
* Contraindications to gastroscopy or general anaesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study will assess if the elimination of the four most common food allergens (cow’s milk, egg, wheat and soy) will induce disease remission in children with EOE.<br><br>Primary outcome measures: histological evidence of eosinophilic oeosphagitis on repeat gastroscopic oesophageal biospy (expresses as number of eosinophils per high power microscopic field)[Patient will be enrolled at the time of the primary diagnosis of untreated eosinophilic oesophagitis (as defined by the presence of at least 20 eosinophils per high power field) on oesophageal histology. Gastroscopy will be repeated after 8-12 weeks, (after the treatment period has been completed) and biopsy and blood samples collected.]