Safety assessment studies of probiotic Saccharomyces boulardii strain Unique 28 in Sprague-Dawley rats

Beneficial Microbes

Volumn 2, Issue 3, 2011, Pages 221-227

  Sudha, M Ratna ^a  

^a Unique Biotech Limited   (India)

Author keywords

Acute toxicity; Probiotics; S. Boulardii unique 28; Safety; Sub acute toxicity

Indexed keywords

PROBIOTIC AGENT;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BACTERIAL STRAIN; BACTERIUM ISOLATION; BODY WEIGHT; CONTROLLED STUDY; DRUG SAFETY; FECES ANALYSIS; FEMALE; FOOD INTAKE; MALE; NONHUMAN; RAT; RISK ASSESSMENT; SACCHAROMYCES BOULARDII; SPRAGUE DAWLEY RAT; TOXICITY TESTING; URINALYSIS;

EID: 81855206647     PISSN: 18762883     EISSN: 18762891     Source Type: Journal    
DOI: 10.3920/BM2011.0013     Document Type: Article

References (21)

1. Bleichner, G., Blehaut, H., Mentec, H. and Moyse, D., 1997. Saccharomyces boulardii prevents diarrhea in critically ill tube-fed patients: a multicenter, randomized, double-blind placebo-controlled trial. Intensive Care 23: 517-523.
2. Cassone, M., Serra, P., Mondello, F., Girolamo, A., Scafetti, S., Pistella, E. and Venditti, M., 2003. Outbreak of Saccharomyces cerevisiae subtype boulardii fungemia in patients neighboring those treated with a probiotic preparation of the organism. Clinical Microbiology 41: 5340-5343.
3. Czerucka, D., Piche, T. and Rampal, P., 2007. Current probiotics - safety assured? Alimentary Pharmacology and Therapeutics 26: 767-778.
4. Duman, D.G., Bor, S., Ozütemiz, O., Sahin, T., Oǧuz, D., Iştan, F., Vural, T., Sandkci, M., Işksal, F., Simşek, I., Soytürk, M., Arslan, S., Sivri, B., Soykan, I., Temizkan, A., Beşşk, F., Kaymakoǧlu, S. and Kalayc, C., 2005. Efficacy and safety of Saccharomyces boulardii in prevention of antibiotic-associated diarrhoea due to Helicobacter pylori eradication. European Journal of Gastroenterology and Hepatology17: 1357-1361.
5. Food and Agricultureal Organization of the United Nations/World Health Organization (FAO/WHO), 2001. Health and nutritional properties of probiotics in food including powder milk with live lactic acid bacteria. Report of a joint FAO/WHO Expert Consultation on evaluation of health and nutritional properties of probiotics in food including powder milk with live lactic acid bacteria. Available at: ftp://ftp.fao.org/es/esn/food/probio_report_en.pdf.
6. Food and Agricultureal Organization of the United Nations/World Health Organization (FAO/WHO), 2002. Guidelines for the evaluation of probiotics in food. Report of a joint FAO/WHO Working Group on drafting guidelines for the evaluation of probiotics in food. London, Ontario, Canada. Available at: http://www.who.int/foodsafety/fs_management/en/probiotic_guidelines.pdf.
7. Lewis, S.J., Potts, L.F. and Barry, R.E., 1998. The lack of therapeutic effect of Saccharomyces boulardii in the prevention of antibiotic-related diarrhoea in elderly patients. Journal of Infection 36: 171-174.
8. Mansour, G.F., Dehbashi, N., Yazdanparast, K. and Shafaghi, A., 2003. Efficacy of Saccharomyces boulardii with antibiotics in acute amoebiasis. World Journal of Gastroenterology 9: 1832-1833.
9. Marteau, R., De Vrese, M., Cellier, C.J. and Schrezenmeir, J., 2001. Protection from gastrointestinal diseases with the use of probiotics. American Journal of Clinical Nutrition 73: 430S-436S.
10. Maupas, J.L., Champemont, P. and Delforge, M., 1983. Treatment of irritable bowel syndrome double blind trial of Saccharomyces boulardii. Medecine et Chirurgie Digestives 12: 77-79.
11. McCullough, M.J., Clemons, K.V. and Steven, M.D., 1998. Species identification and virulence attributes of Saccharomyces boulardii (nom. inval.). Journal of Clinical Microbiology 36: 2613-2617.
12. McFarland, L. and Bernasconi, P., 1993. Saccharomyces boulardii: a review of an innovative biotherapeutic agent. Microbial Ecology in Health and Disease 6: 157-171.
13. Organisation for Economic Co-operation and Development (OECD), 1987. OECD guideline for the testing of chemicals No. 401. Acute oral toxicity. Available at: http://www.oecd-ilibrary.org/environment/test-no-401-acute-oral-toxicity_9789264040113-en.
14. Organisation for Economic Co-operation and Development (OECD), 2008. OECD guideline for the testing of chemicals No. 407. Repeated dose 28-day oral toxicity study in rodents. Available at: http://www.oecd-ilibrary.org/environment/test-no-407-repeated-dose-28-day-oral-toxicity-study-in-rodents_9789264070684-en.
15. Paget, G.E. and Branes, G.M., 1964. Evaluation of drug activities. In: Laurance, D.R. and Bacharach, A.L. (eds.) Pharmacometrics Vol. l. Academic Press, New York, NY, USA, pp. 80-82.
16. Raza, M., Al-Shabanah, O.A., El-Hadiyah T.M. and Al-Majed, A.A., 2002. Effect of prolonged vigabatrin treatment on haematological and biochemical parameters in plasma, liver and kidney of Swiss albino mice. Scientia Pharmaceutica 70: 135-145.
17. Santosa, S., Farnworth, E. and Jones, P.J., 2006. Probiotics and their potential health claims. Nutrition Reviews 64: 265-274.
18. Savaş-Erdeve, S., Gokay, S. and Dallar, Y., 2009. Efficacy and safety of Saccharomyces boulardii in amebiasis-associated diarrhea in children. Turkish Journal of Paediatrics 51: 220-224.
19. Surawicz, C.M., Elmer, G.W., Speelman, P., McFarland, L.V., Chinn, J. and Van Belle, G., 1989. Prevention of antibiotic associated diarrhea by Saccharomyces boulardii: a prospective study. Gastroenterology 96: 981-988.
20. Surawicz, C.M., McFarland, L.V., Greenberg, R.N., Rubin, M., Fekety, R., Mulligan, M.E., Garcia, R.J., Brandmarker, S., Bowen, K., Borjal, D. and Elmer, G.W., 2003. The search for a better treatment for recurrent Clostridium difficile disease: use of high-dose vancomycin combined with Saccharomyces boulardii. Clinical and Infectious Diseases 31: 1012-1017.
21. Tofovic, S.P. and Jackson, E.K., 1999. Effects of long-term caffeine consumption on renal function in spontaneously hypertensive heart failure prone rats. Journal of Cardiovascular Pharmacology 33: 360-366.