Randomized Clinical Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 21, 2015; 21(19): 5985-5994
Published online May 21, 2015. doi: 10.3748/wjg.v21.i19.5985
Effectiveness of probiotic therapy for the prevention of relapse in patients with inactive ulcerative colitis
Yasushi Yoshimatsu, Akihiro Yamada, Ryuichi Furukawa, Koji Sono, Aisaku Osamura, Kentaro Nakamura, Hiroshi Aoki, Yukiko Tsuda, Nobuo Hosoe, Nobuo Takada, Yasuo Suzuki
Yasushi Yoshimatsu, Akihiro Yamada, Ryuichi Furukawa, Koji Sono, Aisaku Osamura, Kentaro Nakamura, Hiroshi Aoki, Yukiko Tsuda, Nobuo Hosoe, Nobuo Takada, Yasuo Suzuki, Department of Internal Medicine, Faculty of Medicine, Toho University, Toho University Sakura Medical Center, Chiba 285-8741, Japan
Author contributions: Yoshimatsu Y and Suzuki Y contributed equally to this work; Yoshimatsu Y and Suzuki Y designed research; Yoshimatsu Y, Yamada A, Furukawa R, Sono K, Osamura A, Nakamura K, Aoki H, Tsuda Y, Hosoe N and Takada N performed research; Yoshimatsu Y and Suzuki Y contributed new reagents/analytic tools; Yoshimatsu Y and Suzuki Y analyzed data; and Yoshimatsu Y and Suzuki Y wrote the paper.
Ethics approval: The study was reviewed and approved by the ethical committee of Toho University Sakura Medical Center.
Informed consent: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest: Yasushi Yoshimatsu has no conflict of interest.
Data sharing: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Yasushi Yoshimatsu, Assistant Professor, Department of Internal Medicine, Faculty of Medicine, Toho University, Toho University Sakura Medical Center, 564-1, Shimoshizu, Sakura, Chiba 285-8741, Japan. 600184yy@sakura.med.toho-u.ac.jp
Telephone: +81-43-4628811 Fax: +81-43-4874246
Received: October 27, 2014
Peer-review started: October 28, 2014
First decision: November 14, 2014
Revised: December 15, 2014
Accepted: February 11, 2015
Article in press: February 11, 2015
Published online: May 21, 2015
Abstract

AIM: To evaluate the effectiveness of probiotic therapy for suppressing relapse in patients with inactive ulcerative colitis (UC).

METHODS: Bio-Three tablets, each containing 2 mg of lactomin (Streptococcus faecalis T-110), 10 mg of Clostridium butyricum TO-A, and 10 mg of Bacillus mesentericus TO-A, were used as probiotic therapy. Sixty outpatients with UC in remission were randomly assigned to receive 9 Bio-Three tablets/day (Bio-Three group) or 9 placebo tablets/day (placebo group) for 12 mo in addition to their ongoing medications. Clinical symptoms were evaluated monthly or on the exacerbation of symptoms or need for additional medication. Fecal samples were collected to analyze bacterial DNA at baseline and 3-mo intervals. Terminal restriction fragment length polymorphism and cluster analyses were done to examine bacterial components of the fecal microflora.

RESULTS: Forty-six patients, 23 in each group, completed the study, and 14 were excluded. The relapse rates in the Bio-Three and placebo groups were respectively 0.0% vs 17.4% at 3 mo (P = 0.036), 8.7% vs 26.1% at 6 mo (P = 0.119), and 21.7% vs 34.8% (P = 0.326) at 9 mo. At 12 mo, the remission rate was 69.5% in the Bio-Three group and 56.6% in the placebo group (P = 0.248). On cluster analysis of fecal flora, 7 patients belonged to cluster I, 32 to cluster II, and 7 to cluster III.

CONCLUSION: Probiotics may be effective for maintaining clinical remission in patients with quiescent UC, especially those who belong to cluster I on fecal bacterial analysis.

Keywords: Ulcerative colitis, Probiotics, Inflammatory bowel disease, Cluster analysis

Core tip: We conducted a single-center, randomized, double-blind, placebo-controlled study to examine whether 12 mo of probiotic therapy was useful for preventing relapse of ulcerative colitis (UC) in patients who were already in remission. The relapse rates in the probiotic therapy group and placebo group were respectively 0.0% vs 17.4% at 3 mo (P = 0.036), 8.7% vs 26.1% at 6 mo (P = 0.119), and 21.7% vs 34.8% (P = 0.326) at 9 mo. At 12 mo, the remission rate was 69.5% in the probiotic therapy group and 56.6% in the placebo group (P = 0.248). Therefor probiotics may be effective for maintaining clinical remission in patients with quiescent UC.