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

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 Results: Two adults with a new diagnosis were withdrawn from the treatment protocol because of intestinal obstruction.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. (The study ID number is UMIN000019061, UMIN000020335: Registration at www. umin.ac.jp).

Recommendation of plant-based diets for inflammatory bowel disease

“…In CD, infliximab combined with PBD induced remission at a rate of 96% in 46 consecutive cases (13). This remission rate is excellent considering that around 30% of sufferers are primary non-responders to infliximab (14) (Figure 2A).…”

“…Although some experts recommend avoidance of dietary fiber in the active phase, our experience refutes this. We provided PBD (containing a high amount of dietary fiber) in the active phase without any problems, even in patients with the stricture form of CD (7,12,13,15,19,20).…”

Evaluation of bowel wall thickness by ultrasound as early diagnostic tool for therapeutic response in Crohn’s disease patients treated with ustekinumab

“…Disease activity was assessed using the CDAI [24]. Our study included patients involving different severity levels (▶ Table 1).…”

Diet and exercise

“…The team will shortly publish results of treating IBD with PBD in conjunction with infliximab, a monoclonal antibody against the cytokine tumour necrosis factor alpha (TNF‐α) that is used to treat autoimmune diseases as well as IBD. The key point is that SVD has been shown to induce remission in some patients who fail to respond to respond to drugs such as infliximab . Furthermore, the team has recently extended the application of SVD to sufferers from ulcerative colitis, again with some promise.…”