Effect of a 4-Food Elimination Diet and Omeprazole in Children with Eosinophilic Esophagitis – A Randomized, Controlled Trial

Abstract

The present trial assessed 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). 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. A second gastroscopy was performed after 8-12 weeks. Complete mucosal remission was defined as eosinophils <5/HPF, and partial remission as <10/HPF on repeat biopsy. Of 64 patients (median age 9.1 yrs) with EoE, 32 were randomized to PPI+4-FED, and 32 to PPI only. There was a higher rate of non-completers in the diet group (5/32 vs 1/32; NS). At baseline, median eosinophil counts were similar between groups (PPI 44.5 [IQR 24-82] vs PPI+4-FED 37 [IQR 21.5-57]; p=0.24). At 8-12 weeks, participants in the PPI+4-FED group had lower median mucosal eosinophil counts, compared to the PPI group (2.5 [IQR 0.5-19] vs 12 [IQR 0-37]; p=0.11). Eosinophil counts were significantly different only in the lower esophagus (PPI+4-FED 2 [IQR 0-18] vs PPI 24 [IQR 5-43]; p=0.003). On per-protocol analysis, at least partial remission (<10 eosinophils/HPF) was significantly more likely for PPI+4-FED vs PPI (88% vs 45%; p=0.002), with borderline significance on intention-to-treat analysis (PPI+4-FED 69% vs PPI 44%; p=0.054). This is the first randomized clinical trial demonstrating that a 4-FED combined with PPI is significantly more effective than PPI monotherapy in children with EoE.