Saccharomyces boulardii

During transit under its viable form in the digestive tract, saccharomyces boulardii exerts biological actions which are similar to the protective properties of the normal intestinal flora.

The principal modes of action of saccharomyces boulardii in prevention and treatment of diarrhoeal syndromes are:

• inhibition of pathogenic effects of certain micro-organisms and/or their toxins especially Clostridium difficile, principal causative organism of antibiotic-associated diarrhoea, and Vibrio cholerae, typical of the toxin-producing bacteria responsible for secretory diarrhoea;
• trophic and immunostimulant effects on the intestinal tract involving notably a significant increase in the total and specific activity of the intestinal disaccharidases (sucrase, maltase and lactase), and a marked increase in secretory IgA concentrations in the intestinal fluid.

Saccharomyces boulardii CNCM I-745 is an intestinal flora replacement which acts as antidiarrheal microorganisms in the digestive tract.

Pharmacodynamics of Saccharomyces boulardii CNCM I-745, live probiotic cultures, have been established on various models by in vitro and in vivo, animal, and human studies which demonstrated it has:

• anti-inflammatory (enterohemorrhagic E. Coli) effect,
• anti-microbial (enterohemorrhagic E. Coli; C. difficile; S. typhimurium; Yersinia enterolitica; C. albicans; C. krusei; C. pseudotropicalis) effect,
• enzymatic (disaccharidases; leucine aminopeptidase; spermine; spermidine) effect,
• metabolic effect,
• anti-toxin (C. diff. toxin A; cholera toxin) effect,
• and immuno-enhancing (secretory-IgA and immunoglobulins) effect

which are beneficial when Saccharomyces boulardii CNCM I-745 is used to treat diarrhea of various origins (infectious viral, bacterial or not) in humans.

Analysis of the fecal elimination kinetics of living S. boulardii CNCM I-745 cells during repeated dosing with 1 g/day of Saccharomyces boulardii CNCM I-745 in healthy adult volunteers showed that steady state is reached by the third day of administration. S. boulardii CNCM I-745 quickly disappears from stools 2 to 5 days after treatment is stopped. Fecal recovery rates follow a linear dose/recovery relation. The recovery rate is more than two-fold higher when subjects take simultaneously an antibiotic (ampicillin) active on the dominant anaerobic flora of the colon. In a clinical trial of patients with multi-recurrent C. difficile infection treated with S. boulardii CNCM I-745 at the dose of 1 g/day, fecal levels of viable yeast cells in patients who did not have subsequent relapses was on average greater than that seen in patients who had a relapse.

--

After repeated oral doses, Saccharomyces boulardii CNCM I-745 transits in the digestive tract without colonizing it, rapidly attaining significant intestinal concentrations which are maintained at a constant level throughout the administration period.

Saccharomyces boulardii CNCM I-745 is no longer present in the stools 2 to 5 days after discontinuation of treatment.

LD50 is much higher than the maximal administered dose of 3,000 mg/kg – repeated dose toxicity has been tested for 6 months in rats and 6 weeks in rabbits without any damage for animals.

An Ames test has been performed and no mutagenic effect has been observed. There is no available data on reproduction.