title: Survival and persistence of Bacillus clausii in the human gastrointestinal tract following oral administration as spore-based probiotic formulation.
abstract: OBJECTIVE
  This study aimed to investigate the fate of Bacillus clausii spores orally administered as lyophilized or liquid formulation to healthy volunteers.
  
  
  RESULTS
  The study was a randomized, open-label, cross-over trial in which two commercial probiotic formulations containing spores of four antibiotic-resistant B. clausii strains (OC, NR, SIN, T) were given as a single dose administration. Faecal B. clausii units of each strain were counted on selective media and extrapolated for the total weight of evacuated faeces. RAPD-PCR typing was used to confirm B. clausii identification. Bacillus clausii was found alive in faeces for up to 12 days. In some volunteers, the recovered amount of OC, NR or SIN was higher than the number of administered spores. Bioequivalence among the two formulations was demonstrated.
  
  
  CONCLUSIONS
  Bacillus clausii spores survive transit through the human gastrointestinal tract. They can undergo germination, outgrowth and multiplication as vegetative forms. Bacillus clausii strains can have different ability to survive in the intestinal environment. Bacillus clausii spores administered as liquid suspension or lyophilized form behave similarly in vivo.
  
  
  CONCLUSIONS
  This work contributes towards a better understanding of the behaviour of B. clausii spores as probiotics.
authors.affiliation: Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.|Research Center Nutraceuticals and Food for Health-Nutrafood, University of Pisa, Pisa, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Ghelardi
authors.affiliation: Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Celandroni
authors.affiliation: Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Salvetti
authors.affiliation: Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
authors.forename: S A
authors.initials: SA
authors.lastname: Gueye
authors.affiliation: Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Lupetti
authors.affiliation: Department of Biology, University of Pisa, Pisa, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Senesi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001407:Bacillus / Q000235:genetics / Q000254:growth & development*; D018592:Cross-Over Studies; D005243:Feces / Q000382:microbiology; D005260:Female; D041981:Gastrointestinal Tract / Q000382:microbiology*; D006801:Humans; D008297:Male; D019936:Probiotics / Q000008:administration & dosage*; D011897:Random Allocation; D019105:Random Amplified Polymorphic DNA Technique; D013171:Spores, Bacterial / Q000235:genetics / Q000254:growth & development
keywords: Bacillus; bacterial spores; gut; human study; oral administration