Preclinical testing in the development of probiotics: A regulatory perspective with Bacillus strains as an example

Clinical Infectious Diseases

Volumn 46, Issue SUPPL. 2, 2008, Pages

  Sorokulova, Iryna ^a,b  

^a ZABOLOTNY INSTITUTE OF MICROBIOLOGY AND VIROLOGY   (Ukraine)

^b AUBURN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PROBIOTIC AGENT;

ANTIBIOTIC RESISTANCE; BACILLUS CEREUS; BACILLUS LICHENIFORMIS; BACILLUS SUBTILIS; BACTERIAL STRAIN; BACTERIAL VIRULENCE; BACTERIUM IDENTIFICATION; BIFIDOBACTERIUM; CONFERENCE PAPER; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG SCREENING; DRUG SYNTHESIS; ENTEROCOCCUS FAECIUM; LACTOBACILLUS; LACTOCOCCUS LACTIS; MOLECULAR TYPING; NONHUMAN; PATHOGENICITY; PRIORITY JOURNAL; RANDOM AMPLIFIED POLYMORPHIC DNA;

ANIMALS; BACILLUS; BACTERIA; CONSUMER PRODUCT SAFETY; DRUG EVALUATION, PRECLINICAL; DRUG RESISTANCE, BACTERIAL; GOVERNMENT REGULATION; HUMANS; MICE; PROBIOTICS;

EID: 40049086803     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/523334     Document Type: Conference Paper

References (40)

1. Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. 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, April 30 and May 1, 2002. Available at: ftp://ftp.fao.org/es/esn/food/wgreport2.pdf. Accessed 16 December 2007.
2. Karimi O, Pena AS. Probiotics: isolated bacteria strain or mixtures of different strains? Two different approaches in the use of probiotics as therapeutics. Drugs Today (Barc) 2003; 39:565-97.
3. Pinchuk IV, Bressollier P, Sorokulova IB, Verneuil B, Urdaci MC. Amicoumacin antibiotic production and genetic diversity of Bacillus subtilis strains isolated from different habitats. Res Microbiol 2002; 153:269-76.
4. Home pages of culture collections in the world. Available at: http://wdcm.nig.ac.jp/hpcc.html. Accessed 16 December 2007.
5. Smirnov VV, Rudenko AV, Samgorodskaia NV, Sorokulova IB, Reznik SR, Sergeichuk TM. Susceptibility to antimicrobial drugs of strains of bacilli used as a basis for various probiotics. Antibiot Khimioter 1994; 39:23-8.
6. Reva ON, Vyunitskaya VA, Reznik SR, Kozachko IA, Smirnov VV. Antibiotic susceptibility as a taxonomic characteristic of the genus Bacillus. Int J Syst Bacteriol 1995; 45:409-11.
7. Temmerman R, Pot B, Huys G, Swings J. Identification and antibiotic susceptibility of bacterial isolates from probiotic products. Int J Food Microbiol 2003; 81:1-10.
8. Moubareck C, Gavini F, Vaugien L, Butel MJ, Doucet-Populaire F. Antimicrobial susceptibility of bifidobacteria. J Antimicrob Chemother 2005; 55:38-44.
9. European Commission on Health and Consumer Protection Directorate-General. Opinion of the Scientific Committee on Animal Nutrition on the criteria for assessing the safety of micro-organisms resistant to antibiotics of human clinical and veterinary importance. 2003:1-21. Available at: http://ec.europa.eu/food/fs/sc/scan/out108_en.pdf. Accessed 16 December 2007.
10. Lund B, Edlund C. Probiotic Enterococcus faecium strain is a possible recipient of the vanA gene cluster. Clin Infect Dis 2001; 32:1384-5.
11. de Niederhausern S, Sabia C, Messi P, Guerrieri E, Manicardi G, Bondi M. Glycopeptide-resistance transferability from vancomycin-resistant enterococci of human and animal source to Listeria spp. Lett Appl Microbiol 2004; 39:483-9.
12. Weigel LM, Donlan RM, Shin DH, et al. High-level vancomycin-resistant Staphylococcus aureus isolates associated with a polymicrobial biofilm. Antimicrob Agents Chemother 2007; 51:231-8.
13. Reid G, Food and Agricultural Organization of the United Nations, World Health Organization. The importance of guidelines in the development and application of probiotics. Curr Pharm Des 2005; 11:11-6.
14. Donohue DC. Safety of probiotics. Asia Pac J Clin Nutr 2006; 15:563-9.
15. Ha GY, Yang CH, Kim H, Chong Y. Case of sepsis caused by Bifidobacterium longum. J Clin Microbiol 1999; 37:1227-8.
16. De Groote MA, Frank DN, Dowell E, Glode MP, Pace NR. Lactobacillus rhamnosus GG bacteremia associated with probiotic use in a child with short gut syndrome. Pediatr Infect Dis J 2005; 24:278-80.
17. European Commission on Health and Consumer Protection Directorate-General. Opinion of the Scientific Committee on Animal Nutrition on the safety of use of Bacillus species in animal nutrition. 2000: 1-18. Available at: http://ec.europa.eu/food/fs/sc/scan/out41_en.pdf. Accessed 16 December 2007.
18. Rowan NJ, Caldow G, Gemmell CG, Hunter IS. Production of diarrheal enterotoxins and other potential virulence factors by veterinary isolates of Bacillus species associated with nongastrointestinal infections. Appl Environ Microbiol 2003; 69:2372-6.
19. Rowan NJ, Deans K, Anderson JG, Gemmell CG, Hunter IS, Chaithong T. Putative virulence factor expression by clinical and food isolates of Bacillus spp. after growth in reconstituted infant milk formulae. Appl Environ Microbiol 2001; 67:3873-81.
20. Aslantas O, Erdogan S, Cantekin Z, Gulacti I, Evrendilek GA. Isolation and characterization of verocytotoxin-producing Escherichia coli O157 from Turkish cattle. Int J Food Microbiol 2006; 106:338-42.
21. Beattie SH, Williams AG. Detection of toxigenic strains of Bacillus cereus and other Bacillus spp. with an improved cytotoxicity assay. Lett Appl Microbiol 1999; 28:221-5.
22. Ishibashi N, Yamazaki S. Probiotics and safety. Am J Clin Nutr 2001; 73:465S-70S.
23. Osipova IG, Sorokulova IB, Tereshkina NV, Grigor'eva LV. Safety of bacteria of the genus Bacillus, forming the base of some probiotics. Zh Mikrobiol Epidemiol Immunobiol 1998; 6:68-70.
24. Sims W. A pathogenic Lactobacillus. J Pathol Bacteriol 1964; 87:99-105.
25. Momose H, Igarashi M, Era T, Fukuda Y, Yamada M, Ogasa K. Toxicological studies on Bifidobacterium longum BB536. Appl Pharmacol 1979; 17:881-7.
26. Tam NKM, Uyen NQ, Hong HA, et al. The intestinal life cycle of Bacillus subtilis and close relatives. J Bacteriol 2006; 188:2692-700.
27. Hong HA, Duc LH, Cutting SM. The use of bacterial spore formers as probiotics. FEMS Microbiol Rev 2005; 29:813-35.
28. Urdaci MC, Pinchuk I. Antimicrobial activity of Bacillus probioics. In: Ricca E, Henriques AO, Cutting SM, eds. Bacterial spore formers: probiotics and emerging applications. Norfolk, United Kingdom: Horizon Bioscience, 2004:171-82.
29. Inatsu Y, Nakamura N, Yuriko Y, Fushimi T, Watanasiritum L, Kawamoto S. Characterization of Bacillus subtilis strains in Thua nao, a traditional fermented soybean food in northern Thailand. Lett Appl Microbiol 2006; 43:237-42.
30. Salvetti S, Celandroni F, Ghelardi E, Baggiani A, Senesi S. Rapid determination of vitamin B2 secretion by bacteria growing on solid media. J Appl Microbiol 2003; 95:1255-60.
31. Chattopadhyay SP, Banerjee AK. Production of valine by a Bacillus sp. Z Allg Mikrobiol 1978; 18:243-54.
32. Kim KP, Rhee CH, Park HD. Degradation of cholesterol by Bacillus subtilis SFF34 isolated from Korean traditional fermented flatfish. Lett Appl Microbiol 2002; 35:468-72.
33. Caldini G, Trotta F, Cenci G. Inhibition of 4-nitroquinoline-1-oxide genotoxicity by Bacillus strains. Res Microbiol 2002; 153:165-71.
34. Caruso A, Flamminio G, Folghera S, et al. Expression of activation markers on peripheral-blood lymphocytes following oral administration of Bacillus subtilis spores. Int J Immunopharmacol 1993; 15:87-92.
35. Sorokulova IB. A comparative study of the biological properties of Biosporin and other commercial Bacillus-based preparations. Mikrobiol Z 1997; 59:43-9.
36. Sorokulova IB, Kirik DL, Pinchuk IV. Probiotics against Campylobacter pathogens. J Travel Med 1997; 4:167-70.
37. Furzikova TM, Sorokulova IB, Serhiichuk MH, Sichkar SV, Smirnov VV. The effect of antibiotic preparations and their combinations with probiotics on the intestinal microflora of mice. Mikrobiol Z 2000; 62:26-35.
38. Paton AW, Morona R, Paton JC. Designer probiotics for prevention of enteric infections. Nat Rev Microbiol 2006; 4:193-200.
39. Sorokulova IB, Beliavskaia VA, Masycheva VA, Smirnov VV. Recombinant probiotics: problems and prospects of their use for medicine and veterinary practice. Vestn Ross Akad Med Nauk 1997; 3:46-9.
40. Seegers JF. Lactobacilli as live vaccine delivery vectors: progress and prospects. Trends Biotechnol 2002; 20:508-15.