Aim: To compare the efficacy and safety of an elemental and a polymeric diet as the primary therapy for active Crohn's disease in children.
Methods: In a randomized, non-blind, multicentre, controlled trial in Sweden, 16 children with Crohn's disease received Elemental 028 Extra (E028E) and 17 Nutrison Standard (NuS). Remission rates (Paediatric Crohn's Disease Activity Index (PCDAI) < 10 or a PCDAI decrease of 40% or 15 points of initial level) were compared at 6 wk.
Results: There was no significant difference between the two groups in remission rate at 6 wk (intent-to-treat analysis): E028E 11/16 (69%) and NuS 14/17 (82%) (p = 0.438). There was no difference in the decrease in PCDAI and CDAI between patients treated with E028E and those treated with NuS from 0 to 6 wk. Patients treated with NuS gained significantly more weight than patients treated with E028E (+2.5 kg; 95% CI 0.9, 4.1; p = 0.004), this difference remained when adjusting for maximum caloric intake per kilogram bodyweight (+2.9 kg; 95% CI 1.4, 4.5; p = 0.001). Concomitant disease, complications and side effects were seen in 5/33 patients (pyelonephritis, pneumonia, intraabdominal abscess, perianal abscess and borborygmi).
Conclusion: E028E and NuS did not differ in terms of remission rate. Patients treated with NuS gained more weight than patients with E028E. Polymeric diet may be superior to elemental diet in the treatment of paediatric Crohn's disease where the primary aim is to increase the patient's weight.