Tolerance and Effect of a Probiotic Supplement Delivered in Capsule Form

Abstract

Probiotic supplements have shown benefits in increasing frequency and efficiency of bowel movements and some strains have shown to reduce serum glucose levels. Bacillus subtilis is used in the fermentation of some foods for probiotic effects and may be useful in concentrated supplement form. The first objective of this clinical study was to determine if daily consumption of Bacillus subtilis strain DE111 at a dose of 5 × 10 9 CFU is safe for human consumption. The second objective was to determine the effectiveness at increasing frequency of normal bowel movements and improving consistency of bowel type, by increasing beneficial gut microbes and reducing pathogenic ones. The tolerance and efficacy of encapsulated Bacillus subtilis DE111 was assessed in an average 20-day double-blind, randomized, and placebo-controlled human study. Most blood parameters remained within normal ranges throughout; however, fasted serum glucose levels in the probiotic group (91.0 ± 1.0 to 85.9 ± 1.4 mg/dl, α ≤ 0.05; P = 0.012) were significantly reduced. Although there was a significant increase in the average number of bowel movements per day within the placebo group ( α ≤ 0.05; P = 0.015), there was no significant change in the type. Triglyceride levels were maintained within the probiotic group, while the control group displayed a significant increase from pre to post by paired T-test ( α ≤ 0.05; P ≤ 0.042) (Figure 2). Additionally, significant differences in microbe colonization were present for Bacillus subtilis and Bifidobacterium in the fecal colony counts. Daily consumption of Bacillus subtilis can be recognized as safe, and has potential to be effective as a supplement to improve glucose tolerance.