*Recruitment Closed*

Study short name: 4-FEED

Study full name: Effects of diet and Omeprazole in patients with eosinophilic oesophagitis – a multi-centre, randomised controlled trial and investigation of novel disease mechanisms

Principle Investigator: Katie Allen

Administering Institute: Royal Children’s Hospital

Major funding source: National Health and Medical Research Council (NHMRC)

Study focus: Treatment

Study design: Intervention

Main study aim: To assess whether a 4-food elimination diet (4-FED), in combination with proton pump inhibitor (PPI) treatment, is superior to PPI monotherapy in children with eosinophilic esophagitis (EoE).

Additional study information: After a baseline gastroscopy, patients with histologically proven EoE (≥15 eosinophils per high power field; HPF) were randomized to omeprazole 1mg/kg twice daily (max. dose 20mg b.i.d.) plus a 4-FED (cow’s milk, soy, egg, wheat) vs omeprazole monotherapy.

Study Population: Children with EOE aged 0-18 years.

Study status: Recruitment completed December 2016. Data collection completed December 2016.

Where can I find more information?

Study contact: [email protected]

Main Publication(s):

  1. Heine RG, Peters R, Cameron DJ, Alex G, Oliver MR, Hardikar W, et al. Effect of a 4-Food Elimination Diet and Omeprazole in Children with Eosinophilic Esophagitis – A Randomized, Controlled Trial. Journal of Allergy and Clinical Immunology. 2019;143(2):Ab309-Ab309. doi: https://doi.org/10.1016/j.jaci.2018.12.941.

Last modified: December 12th 2019 | Date created: April 9th 2019