Source: Υπουργείο Υγείας (CY) Revision Year: 2021
ANTI-DIARRHOEA
Replacement flora
Pharmacotherapeutic group: A, digestive system and metabolism
ATC code: A07FA02
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:
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.
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.
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