Enteral Feeding Therapy for Newly Diagnosed Pediatric Crohnʼs Disease: A Double-Blind Randomized Controlled Trial with Two Years Follow-Up§

Abstract

This study compared the efficacy of an elemental formula (EF) to a polymeric formula (PF) in inducing remission for pediatric Crohn's disease (CD). Newly diagnosed CD children were randomized to EF or PF for 6 weeks. Change in the Pediatric Crohn's Disease Activity Index (PCDAI), fecal calprotectin, and plasma fatty acids were measured at 0 and 6 weeks. Patients were followed up for 2 years. Time and treatment choice for first relapse were documented. Thirty-four children completed the study; EF: 15 (7 M, 8 F), PF: 19 (13 M, 6 F). The mean age was (years) EF: 12.6, PF: 11.7. Ninety-three percent of children (14/15) achieved remission in the EF group and 79% (15/19) in the PF group. One-third of patients maintained remission for 2 years. Mean time to relapse (days); EF: 183 (63-286), PF: 162 (53-301). Most children who relapsed used feed as a treatment for that relapse (EF: 9/10 and PF: 8/13). With PF, an increase of eicosapentanoic acid (EPA) and alpha linolenic acid was found with a reciprocal decrease in arachidonic acid (AA). With EF, AA and EPA levels were reduced with a significant decrease in docosahexaenoic acid. Fecal calprotectin measurements decreased significantly but did not normalize at the end of week 6. There was no significant difference between EF and PF in inducing remission. One-third of children maintained remission. Changes in plasma polyunsaturated fatty acid status were subtle and may be relevant; however, further evaluation is recommended.