Mitsuro Chiba1, Tsuyotoshi Tsuji2, Kunio Nakane3, Satoko Tsuda4, Hajime Ishii5, Hideo Ohno6, Kenta Watanabe7, Mai Ito8, Masafumi Komatsu9, Takeshi Sugawara10. 1. Chief of the Inflammatory Bowel Disease Section at Akita City Hospital in Japan. mchiba@m2.gyao.ne.jp. 2. Chief of the Gastrointestinal Endoscopy Section at Akita City Hospital in Japan. ac070289@akita-city-hp.jp. 3. Chief of the Gastroenterology Division at Akita City Hospital in Japan. ac060950@akita-city-hp.jp. 4. Gastroenterologist at Akita City Hospital in Japan. satokotsuda07@gmail.com. 5. Gastroenterologist at Akita City Hospital in Japan. acd00377@akita-city-hp.jp. 6. Gastroenterologist at Akita City Hospital in Japan. ac120502@akita-city-hp.jp. 7. Gastroenterologist at Akita City Hospital in Japan. nabeken_9989@yahoo.co.jp. 8. Gastroenterologist at Akita City Hospital in Japan. pixmon1231@gmail.com. 9. Gastroenterologist and the Director of Akita City Hospital, in Japan. ac990892@akita-city-hp.jp. 10. Gastroenterologist at Nakadori General Hospital in Japan. nrp05157@nifty.com.
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 RESULTS: Two adults with a new diagnosis were withdrawn from the treatment protocol because of intestinal obstruction.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.
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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