4-FEED

Status

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.

Study contact: [email protected]

Main Publication(s):

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.