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. Design: The study was designed as a randomized, placebo-controlled, double-blinded, parallel dose-response study. Subjects: 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. Intervention: 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 (Po0.001) 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 ¼ 0.018) was observed. No overall dose-response effect was found on the blood lipids. High doses of probiotics were well tolerated. Conclusion: A dose-related recovery of BB-12 from feces was observed. Sponsorship: The study was sponsored by Chr. Hansen A/S, Hoersholm, Denmark. Keywords: dose-response study; probiotics; cholesterol; recovery from feces; constipation
European Journal of Clinical Nutrition
IntroductionIt is generally accepted that the composition of the intestinal microflora influences the health and well being of humans. With the many publications showing beneficial effects of probiotic bacteria, there has been an increasing interest in the mechanism behind. Most clinical studies have tested only one dose of probiotics, ranging from 4 Â 10 8 CFU/day for determination of gastrointestinal colonization and immune modulation (Valeur et al., 2004) Contributors: DCE, CNL and KFM wrote the protocol. DCE performed the study. CNL did the microbiological analysis of fecal samples and study product. EB performed the fluorescent whole cell hybridization of BB-12 like colonies. MB performed the PFGE of CRL-431 like colonies. PK performed the statistical analysis. CNL and SN wrote the first draft of the paper and all contributors participated in the revision and final approval of the paper.