The effect of Clostridium butyricum MIYAIRI on the prevention of pouchitis and alteration of the microbiota profile in patients with ulcerative colitis.

Asuka Yasueda, Tsunekazu Mizushima, Riichiro Nezu, Ryoko Sumi, Mamoru Tanaka, Junichi Nishimura, Yasuyuki Kai, Masaki Hirota, Hideki Osawa, Kiyokazu Nakajima, Masaki Mori, Toshinori Ito

Journal: Surgery today 2017;46(8):939-49

PMID: 26510664

Abstract

PURPOSE

Ulcerative colitis (UC) is a chronic, relapsing, and refractory disorder of the intestine. Total proctocolectomy with ileal pouch anal anastomosis (IPAA) is the preferred and standard surgical procedure for patients' refractory to medical therapy. Pouchitis is one of the most common long-term complications after IPAA. In the present study, the safety and efficacy of Clostridium butyricum MIYAIRI (CBM) as a probiotic were examined.

METHODS

A randomized and placebo-controlled study was performed. Seventeen patients were recruited from 2007 to 2013. Nine tablets of MIYA-BM(®) or placebo were orally administered once daily. The cumulative pouchitis-free survival, pouch condition (using the modified pouch disease activity index), and blood parameters were evaluated. A fecal sample analysis was also performed.

RESULTS

Subjects were randomly allocated to receive MIYA-BM or placebo (9 and 8 subjects, respectively). One subject in the MIYA-BM group and four subjects in the placebo group developed pouchitis. No side effects occurred in either group. Characteristic intestinal flora was observed in each group.

CONCLUSIONS

Our results suggest that probiotic therapy with CBM achieved favorable results with minimal side effects and might be a useful complementary therapy for the prevention of pouchitis in patients with UC who have undergone IPAA.

Address: Department of Integrative Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.; Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.; Department of Therapeutics for Inflammatory Bowel Diseases, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.; Department of Surgery, Nishinomiya Municipal Central Hospital, 8-24 Hayashidacho, Nishinomiya, Hyogo, 663-8014, Japan.; Division of Nutrition and Medical Engineering, Center for Advanced Medical Engineering and Informatics, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.; Miyarisan Pharmaceutical Co. Ltd., 102-15 Sakaki, Hanishina, Nagano, 389-0682, Japan.; Gastroenterological Surgery, Hanwasumiyoshi General Hospital, 3-2-9 Minami Sumiyoshi, Sumiyoshi-ku, Osaka, 558-0041, Japan.; Gastroenterological Surgery, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.; Division of Collaborative Research for Next Generation Endoscopic Intervention, Center for Advanced Medical Engineering and Informatics, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.; Department of Integrative Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. [email protected].
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