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. 2017:21:17-009.
doi: 10.7812/TPP/17-009.

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

Affiliations

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

Mitsuro Chiba et al. Perm J. 2017.

Abstract

Background: Approximately 30% of patients with Crohn disease (CD) are unresponsive to biologics. 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 naïve 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Results: Two adults with a new diagnosis were withdrawn from the treatment protocol because of intestinal obstruction.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 naïve to biologics regardless of age or whether they have a new diagnosis or relapse.

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Conflict of interest statement

Disclosure Statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Enrollment of inpatients with active Crohn disease for IPF therapy. IPF therapy = infliximab and plant-based diet as first-line therapy; ITT = intention to treat; PP = per protocol.
Figure 2
Figure 2
Change of CDAI score (upper panel) and CRP concentration (lower panel) before and after IPF therapy in 44 patients with CD. The solid bar denotes the mean and the thin line shows the standard deviation. Arrows with numbers in brackets indicate 3 infliximab infusions at weeks 0, 2, and 6. CDAI score and CRP concentration (mg/dL) (reference range ≤ 0.3) are presented in Table 3. All CDAI scores and CRP concentrations significantly decreased after IPF (analysis of variance p < 0.0001, Tukey-Kramer honestly significant difference test p < 0.0001). CD = Crohn disease; CDAI = Crohn Disease Activity Index; CRP = C-reactive protein; IPF therapy = infliximab and a plant-based diet as first-line therapy.

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