Prospective clinical trial: enteral nutrition during maintenance infliximab in Crohn's disease.

<bold>Purpose: </bold>Hitherto, the efficacy of enteral nutrition (EN) on clinical outcomes during biological maintenance therapy in Crohn's disease (CD) has not been investigated. This prospective study was to assess the efficacy of EN on the maintenance rate of clinical remission in patients with quiescent CD receiving infliximab as maintenance therapy.<bold>Methods: </bold>Fifty-six patients who achieved clinical remission with infliximab induction therapy received infliximab as maintenance therapy (5 mg/kg, every 8 weeks). Thirty-two of the 56 patients received concomitant EN: elemental diet infusion during night-time and a low fat diet during daytime (EN group), while the remaining 24 patients received neither nutritional therapy nor food restriction (non-EN group). All patients were followed for 56 weeks; CD activity index (CDAI) was assessed and CDAI < 150 was defined as clinical remission.<bold>Results: </bold>During the 56-week observation, the mean CDAI was not significantly different between the 2 groups. Seven patients in the EN group ceased EN therapy because they maintained complete remission. On an intention-to-treat basis, 25 patients in the EN group (78%) and 16 patients in the non-EN group (67%) remained in clinical remission during the 56-week observation (P = 0.51).<bold>Conclusions: </bold>The outcomes of this prospective study showed that concomitant EN during infliximab maintenance therapy does not significantly increase the maintenance rate of clinical remission in patients with CD. [ABSTRACT FROM AUTHOR]