Enteral feeding therapy for newly diagnosed pediatric Crohn's disease: a double-blind randomized controlled trial with two years follow-up

Abstract

Background: This study compared the efficacy of an elemental formula (EF) to a polymeric formula (PF) in inducing remission for pediatric Crohn's disease (CD).

Methods: 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.

Results: 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.

Conclusions: 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.