title: Dose-response study of probiotic bacteria Bifidobacterium animalis subsp lactis BB-12 and Lactobacillus paracasei subsp paracasei CRL-341 in healthy young adults.
abstract: OBJECTIVE
  This study was performed to investigate the dose-response effects of supplementation with Bifidobacterium animalis subsp lactis (BB-12) and Lactobacillus paracasei subsp paracasei (CRL-431) on blood lipids, recovery from feces and bowel habits. Changes of the fecal microflora was analyzed in the 10(10) CFU/day probiotic and placebo group.
  
  
  METHODS
  The study was designed as a randomized, placebo-controlled, double-blinded, parallel dose-response study.
  
  
  METHODS
  Healthy young adults (18-40 years) were recruited by advertising in local newspapers. Of the 75 persons enrolled, 71 (46 women, 25 men, mean age 25.6 years (range 18-40 years)) completed the study.
  
  
  METHODS
  The volunteers were randomly assigned into five groups receiving either placebo or a mixture of the two probiotics in the concentration of 10(8), 10(9), 10(10) or 10(11) CFU/day in 2 weeks run-in period, 3 weeks intervention and 2 weeks wash-out. Diary reporting bowel habits and well being (abdominal bloating, flatulence and headache) was kept for all 7 weeks and blood lipids, fecal recovery of BB-12 and CRL-431, as well as fecal microflora was tested before, immediately and 2 weeks after intervention.
  
  
  RESULTS
  The fecal recovery of BB-12 increased significantly (P < 0.001) with increasing dose. In the group receiving 10(11) CFU/day BB-12 was recovered from 13 out of 15 volunteers. CRL-431 was not recovered in any of the fecal samples. Supplementation with probiotics did not change the fecal bacterial composition. A significant linear increase in fecal consistency (looser stool) with increasing probiotic dose (P = 0.018) was observed. No overall dose-response effect was found on the blood lipids. High doses of probiotics were well tolerated.
  
  
  CONCLUSIONS
  A dose-related recovery of BB-12 from feces was observed.
authors.affiliation: Chr. Hansen A/S, Hoersholm, Denmark.
authors.forename: C N
authors.initials: CN
authors.lastname: Larsen
authors.forename: S
authors.initials: S
authors.lastname: Nielsen
authors.forename: P
authors.initials: P
authors.lastname: Kaestel
authors.forename: E
authors.initials: E
authors.lastname: Brockmann
authors.forename: M
authors.initials: M
authors.lastname: Bennedsen
authors.forename: H R
authors.initials: HR
authors.lastname: Christensen
authors.forename: D C
authors.initials: DC
authors.lastname: Eskesen
authors.forename: B L
authors.initials: BL
authors.lastname: Jacobsen
authors.forename: K F
authors.initials: KF
authors.lastname: Michaelsen
mesh_terms: D000293:Adolescent; D000328:Adult; D001644:Bifidobacterium / Q000254:growth & development*; D015169:Colony Count, Microbial; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005243:Feces / Q000382:microbiology; D005260:Female; D005414:Flatulence / Q000453:epidemiology; D006801:Humans; D007778:Lactobacillus / Q000254:growth & development*; D008055:Lipids / Q000097:blood*; D008297:Male; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D008055:Lipids