Abstract
ObjectiveContinuous intake of Bacillus subtilis C-3102 (B. subtilis C-3102) has been reported to modulate the gut microbiota and increase the bone mineral density of the femur in healthy adults. This study aimed to evaluate the safety of excessive B. subtilis C-3102 intake through a randomized, placebo-controlled, double-blind, parallel-group study. MethodA total of 69 individuals provided an informed consent, and 44 subjects who met the inclusion criteria were allocated to either the B. subtilis C-3102 (C-3102 group, n = 22) or the placebo group (P group, n = 22). All subjects took 18 tablets containing either containing B. subtilis C-3102 or placebo per day for 4 weeks with water and without chewing. Subjects in the C-3102 group consumed 4.8 × 1010 colony forming units (cfu) per day. Physical examination, urinalysis, blood analysis, records of subjective symptoms, and a medical questionnaire administered by a clinical trial physician were performed to determine the safety of test tablets. Furthermore, bone mineral density was measured. ResultsThe final analysis included data from 22 subjects (9 men, 13 women; age, 46.1 ± 13.8 years) in the C-3102 group and 22 subjects (9 men, 13 women; age, 46.1 ± 13.5 years) in the P group. The results revealed no medical-related problems in both C-3102 and P groups. ConclusionThis study proved the safety of 4-week continuous consumption of an excessive amount of B. subtilis C-3102 tablets.
Highlights
100 trillion bacteria and microbes reside in the intestines of humans, forming diverse colonies [1]; these are referred to as gut microbiota
The composition and metabolism of gut microbiota are influenced by dietary habitation [2], stress [3], aging [4], and other factors, and are affected by several diseases [5], which lowers the quality of life
A previous clinical study demonstrated that an intake of 9.0 × 108 cfu of Bacillus subtilis C-3102 for 8 days significantly reduced para-cresol concentration and coliform bacterial counts in feces and significantly increased the relative abundance of genera Bifidobacterium [6]
Summary
100 trillion bacteria and microbes reside in the intestines of humans, forming diverse colonies [1]; these are referred to as gut microbiota. Improving the intestinal environment is essential for health maintenance and promotion. A previous clinical study demonstrated that an intake of 9.0 × 108 cfu of Bacillus subtilis C-3102 (hereinafter referred to as C-31021) for 8 days significantly reduced para-cresol concentration and coliform bacterial counts in feces and significantly increased the relative abundance of genera Bifidobacterium [6]. The intake of 2.2 × 109 cfu of C-3102 per day for 8 weeks in healthy subjects having loose stools significantly lowered the Bristol scale score and stool frequency and modulated the gut microbiota [7].
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