None listed
Conditions
Brief summary
Eosinophilic oesophagitis (EOE) is a recently discovered condition which involves allergic inflammation in the oesophagus. This research project aims to conduct the first study of a dietary intervention for the treatment of EOE in children. As part of the research we also aim to mechanistic studies into the pathophysiology of this condition. This study is being completed in two stages. In Stage 1, children with suspected EOE undergoing gastroscopy will be invited to take part into the study. Only patients with confirmed EOE will progress to stage 2 of the study. In Stage 2, children with confirmed EOE will be randomly allocated to one of two interventions: four-food elimination diet (avoiding cow's milk, egg, soy and wheat) plus omeprazole, versus omeprazole alone as the control intervention (for 8 -12 weeks in each arm of the study).
Interventions
We aim to conduct the first randomised, controlled trial (RCT) of a dietary intervention for the treatment of eosinophilic oesophagitis (EOE) in children.
Group 1: Active treatment ,Oral Proton Pump Inhibitor (PPI) plus elimination diet)
8-12 week treatment with omeprazole (Losec [registered trademark]) for 8-12 weeks plus, four-food elimination diet (strictly avoiding all foods containing cow’s milk, soy, wheat or egg) during this 8-12 week period (as supervised by paediatric dietitian).
Par
We aim to conduct the first randomised, controlled trial (RCT) of a dietary intervention for the treatment of eosinophilic oesophagitis (EOE) in children. Group 1: Active treatment ,Oral Proton Pump Inhibitor (PPI) plus elimination diet) 8-12 week treatment with omeprazole (Losec [registered trademark]) for 8-12 weeks plus, four-food elimination diet (strictly avoiding all foods containing cow’s milk, soy, wheat or egg) during this 8-12 week period (as supervised by paediatric dietitian). Participant will undergo gastroscopy and biopsies at the start and end of the treatment period to assess for histological response to the intervention. Omeprazole dosage amount is as follows: 7.5 – 9.9 kg: 5mg mane and 10mg nocte, 10.0 – 14.9 kg:10 mg twice daily, 15.0 – 19.9 kg:15 mg twice daily, >20 kg: 20 mg twice daily. Medication will be dispensed at commencement of the study, after 4 weeks and if participant is currently active on the study at 10 week point also. Medication will be collected at 4 weeks, and at the follow-up endoscopy to measure compliance. The treatment period of between 8-12 weeks is determined by the demand on endoscopy hospital bookings.
Sponsors
Murdoch Childrens Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Healthy volunteers
No
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
Outcome results
None listed