Induction with Infliximab and a Plant-Based Diet as First-Line (IPF) Therapy for Crohn Disease: A Single-Group Trial.

Background: Approximately 30% of patients with Crohn disease (CD) are unresponsive to biologies. No previous study has focused on a plant-based diet in an induction phase of CD treatment. Objective: To investigate the remission rate of infliximab combined with a plant-based diet as first-line (IPF) therapy for CD. Methods: This was a prospective single-group trial conducted at tertiary hospitals. Subjects included consecutive adults with a new diagnosis (n = 26), children with a new diagnosis (n = 11), and relapsing adults (n = 9) with CD who were naive to treatment with biologics. Patients were admitted and administered a standard induction therapy with infliximab (5 mg/kg; 3 infusions at 0, 2, and 6 weeks). Additionally, they received a lacto-ovo-semivegetarian diet. The primary end point was remission, defined as the disappearance of active CD symptoms at week 6. Secondary end points were Crohn Disease Activity Index (CDAI) score, C-reactive protein (CRP) concentration, and mucosal healing. Results: Two adults with a new diagnosis were withdrawn from the treatment protocol because of intestinal obstruction. The remission rates by the intention-to-treat and per-protocol analyses were 96% (44/46) and 100% (44/44), respectively. Mean CDAI score (314) on admission decreased to 63 at week 6 (p < 0.0001). Mean CRP level on admission (5.3 mg/dL) decreased to 0.2 (p < 0.0001). Mucosal healing was achieved in 46% (19/41) of cases. Conclusion: IPF therapy can induce remission in most patients with CD who are naive to biologics regardless of age or whether they have a new diagnosis or relapse. (The study ID number is UMIN000019061, UMIN000020335: Registration at www. umin.ac.jp). [ABSTRACT FROM AUTHOR]