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Safety assessment of Bacillus subtilis CU1 for use as a probiotic in humans

dc.contributor.authorLEFEVRE, Marie
hal.structure.identifierChimie et Biologie des Membranes et des Nanoobjets [CBMN]
dc.contributor.authorRACEDO, Silvia Maria
hal.structure.identifierChimie et Biologie des Membranes et des Nanoobjets [CBMN]
dc.contributor.authorDENAYROLLES, Muriel
ORCID: 0000-0002-7458-9263
IDREF: 131894013
hal.structure.identifierChimie et Biologie des Membranes et des Nanoobjets [CBMN]
dc.contributor.authorRIPERT, Gabrielle
dc.contributor.authorDESFOUGERES, T.
dc.contributor.authorLOBACH, A. R.
dc.contributor.authorSIMON, R.
dc.contributor.authorPELERIN, F.
dc.contributor.authorJUSTEN, P.
hal.structure.identifierChimie et Biologie des Membranes et des Nanoobjets [CBMN]
dc.contributor.authorURDACI, Maria C.
ORCID: 0000-0002-0868-0050
IDREF: 033307679
dc.date.accessioned2020-07-09T14:16:46Z
dc.date.available2020-07-09T14:16:46Z
dc.date.issued2017-02
dc.identifier.issn0273-2300
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/10300
dc.description.abstractEnBacillus subtilis CU1 is a recently described probiotic strain with beneficial effects on immune health in elderly subjects. The following work describes a series of studies supporting the safety of the strain for use as an ingredient in food and supplement preparations. Using a combination of 16S rDNA and gyrB nucleotide analyses, the species was identified as a member of the Bacillus subtilis complex (B. subtilis subsp. spizizenii). Further characterization of the organism at the strain level was achieved using random amplified polymorphic DNA polymerase chain reaction (RAPD PCR) and pulsed field gel electrophoresis (PFGE) analyses. B. subtilis CU1 did not demonstrate antibiotic resistance greater than existing regulatory cutoffs against clinically important antibiotics, did not induce hemolysis or produce surfactant factors, and was absent of toxigenic activity in vitro. Use of B. subtilis CU1 as a probiotic has recently been evaluated in a 16-week randomized, double-blind, placebo-controlled, parallel-arm study, in which 2 x 10(9) spores per day of B. subtilis CU1 were administered for a total 40 days to healthy elderly subjects (4 consumption periods of 10 days separated by 18-day washouts). This work describes safety related endpoints not previously reported. B. subtilis CU1 was safe and well-tolerated in the clinical subjects without undesirable physiological effects on markers of liver and kidney function, complete blood counts, hemodynamic parameters, and vital signs. (C) 2016 The Authors. Published by Elsevier Inc.
dc.title.enSafety assessment of Bacillus subtilis CU1 for use as a probiotic in humans
dc.typeArticle de revue
dc.identifier.doi10.1016/j.yrtph.2016.11.010
dc.subject.halChimie/Matériaux
bordeaux.journalRegulatory Toxicology and Pharmacology
bordeaux.page54-65
bordeaux.volume83
bordeaux.hal.laboratoriesInstitut de Chimie & de Biologie des Membranes & des Nano-objets (CBMN) - UMR 5248*
bordeaux.hal.laboratoriesInstitut de Chimie & de Biologie des Membranes & des Nano-objets (CBMN, UMR 5248)
bordeaux.institutionUniversité de Bordeaux
bordeaux.institutionBordeaux INP
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