title: A Double-Blind, Randomized, Active Drug Comparative, Parallel-Group, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Probiotics (Bacillus licheniformis, Zhengchangsheng® capsule) in Patients with Diarrhea.
abstract: OBJECTIVE
  Bacillus Licheniformis, a probiotic used in the treatment of diarrhea, has been shown to suppress the growth of pathologic bacteria. This study was performed to assess the therapeutic efficacy and safety of Zhengchangsheng® (Bacillus Licheniformis) in comparison with another probiotic, Bioflor® (Saccharomyces Boulardii) for the treatment of diarrhea.
  
  
  METHODS
  Patients with diarrhea (n=158) were randomized to receive Zhengchangsheng® or Bioflor® for 5 days. The existence or non-existence of formed feces, changes in daily stool frequency, improvement of subjective symptoms, and changes in the severity of diarrhea were compared.
  
  
  RESULTS
  Of the 158 full analysis set (FAS) patient population, 151 patients comprised the per protocol (PP) analysis. The rates of recovered to formed feces in the Bacillus and Saccharomyces groups were 91.0% vs. 95.0% in the FAS (P=0.326) and 90.5% vs. 96.1% in the PP analysis (P=0.169), respectively. The mean duration of diarrhea changing to formed feces was 3.15±1.10 days in the Bacillus group and 3.22±1.01 in the Saccharomyces group (P=0.695, FAS). The frequency of defecation, subjective symptoms, and degree of severe diarrhea were improved in both groups, however, there were no statistically significant differences between the 2 groups. Analysis of the 95% confidence intervals for the differences in the rate of recovery to formed feces between the 2 groups met the criteria for non-inferiority of Bacillus compared to Saccharomyces. No significant adverse events were observed during the study period.
  
  
  CONCLUSIONS
  Zhengchangsheng® is not inferior to Bioflor® in therapeutic efficacy and is a safe and useful therapeutic agent for the treatment of diarrhea.
authors.affiliation: Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
authors.forename: Jun
authors.initials: J
authors.lastname: Heo
authors.affiliation: Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
authors.forename: Sung Kook
authors.initials: SK
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine Division of Gastroenterology, Keimyung University School of Medicine, Daegu, Korea.
authors.forename: Kyung Sik
authors.initials: KS
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
authors.forename: Hye Kyung
authors.initials: HK
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
authors.forename: Joong Goo
authors.initials: JG
authors.lastname: Kwon
authors.affiliation: Department of Internal Medicine, Yeungnam University, College of Medicine, Daegu, Korea.
authors.forename: Byung Ik
authors.initials: BI
authors.lastname: Jang
keywords: Bacillus Licheniformis; Diarrhea; Probiotics