Dose–response study of probiotic bacteria Bifidobacterium animalis subsp lactis BB-12 and Lactobacillus paracasei subsp paracasei CRL-341 in healthy young adults

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Abstract
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 1010 CFU/day probiotic and placebo group. The study was designed as a randomized, placebo-controlled, double-blinded, parallel dose–response study. 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. The volunteers were randomly assigned into five groups receiving either placebo or a mixture of the two probiotics in the concentration of 108, 109, 1010 or 1011 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. The fecal recovery of BB-12 increased significantly (P11 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. A dose-related recovery of BB-12 from feces was observed. The study was sponsored by Chr. Hansen A/S, Hoersholm, Denmark.