The effect of Clostridium butyricum MIYAIRI on the prevention of pouchitis and alteration of the microbiota profile in patients with ulcerative colitis.
OBJECTIVE
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.
Department of Integrative Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Asuka
A
Yasueda
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.
Tsunekazu
T
Mizushima
Department of Surgery, Nishinomiya Municipal Central Hospital, 8-24 Hayashidacho, Nishinomiya, Hyogo, 663-8014, Japan.
Riichiro
R
Nezu
Division of Nutrition and Medical Engineering, Center for Advanced Medical Engineering and Informatics, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Ryoko
R
Sumi
Miyarisan Pharmaceutical Co. Ltd., 102-15 Sakaki, Hanishina, Nagano, 389-0682, Japan.
Mamoru
M
Tanaka
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Junichi
J
Nishimura
Gastroenterological Surgery, Hanwasumiyoshi General Hospital, 3-2-9 Minami Sumiyoshi, Sumiyoshi-ku, Osaka, 558-0041, Japan.
Yasuyuki
Y
Kai
Gastroenterological Surgery, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.
Masaki
M
Hirota
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Hideki
H
Osawa
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.
Kiyokazu
K
Nakajima
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Masaki
M
Mori
Department of Integrative Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. juki@cam.med.osaka-u.ac.jp.
Toshinori
T
Ito
D000284:Administration, Oral; D000328:Adult; D000714:Anastomosis, Surgical; D046972:Clostridium butyricum; D003093:Colitis, Ulcerative / Q000382:microbiology* / Q000601:surgery*; D039021:Colonic Pouches / Q000382:microbiology; D005260:Female; D000069196:Gastrointestinal Microbiome; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D019449:Pouchitis / Q000517:prevention & control*; D019936:Probiotics / Q000008:administration & dosage*; D016737:Proctocolectomy, Restorative
Clostridium butyricum MIYAIRI; IPAA; Pouchitis; Probiotics; Ulcerative colitis