TY - JOUR
T1 - Short-term, daily intake of yogurt containing Bifidobacterium animalis ssp. lactis Bf-6 (LMG 24384) does not affect colonic transit time in women
AU - Merenstein, Daniel J.
AU - D'Amico, Frank
AU - Palese, Caren
AU - Hahn, Alexander
AU - Sparenborg, Jessy
AU - Tan, Tina
AU - Scott, Hillary
AU - Polzin, Kayla
AU - Kolberg, Lore
AU - Roberts, Robert
PY - 2014/1/28
Y1 - 2014/1/28
N2 - The present study investigated the effect of Bifidobacterium animalis ssp. lactis Bf-6 (LMG 24384) (Bf-6)-supplemented yogurt on colonic transit time (CTT). A triple-blinded, randomised, placebo-controlled, two-period cross-over trial was conducted with sixty-eight women with a self-reported history of straining during bowel movements or hard or lumpy stools in the past 2 years. As per regulatory requirements for probiotic studies, eligible women were generally healthy and not actively constipated at the time of enrolment. Participants consumed both Bf-6 and placebo yogurts for 14d each in a randomised order, with a 6-week washout period between the treatments. The primary outcome, CTT, was assessed via Sitz marker X-rays. The average CTT was 42·1h for the active period and 43·3h for the control period (mean difference 1·2h, 95% CI-4·9, 7·4). Since the statistical tests for the cross-over study implied that the mean CTT for the active and control periods in period 2 were biased, the standard protocol suggests examining the results of only period 1 as a traditional randomised controlled trial. This showed that the mean CTT was 35·2h for the active period v. 52·9h for the control period (P=0·015). Bootstrapping demonstrated that both the mean and median differences remained significant (P=0·016 and P=0·045, respectively). Few adverse events were noted, with no differences among the active and control periods. The paired analysis showed no differences between the active and control periods during the cross-over trial. Further trials should be conducted in populations with underlying problems associated with disordered transit to determine the potential value of probiotic supplementation more accurately.
AB - The present study investigated the effect of Bifidobacterium animalis ssp. lactis Bf-6 (LMG 24384) (Bf-6)-supplemented yogurt on colonic transit time (CTT). A triple-blinded, randomised, placebo-controlled, two-period cross-over trial was conducted with sixty-eight women with a self-reported history of straining during bowel movements or hard or lumpy stools in the past 2 years. As per regulatory requirements for probiotic studies, eligible women were generally healthy and not actively constipated at the time of enrolment. Participants consumed both Bf-6 and placebo yogurts for 14d each in a randomised order, with a 6-week washout period between the treatments. The primary outcome, CTT, was assessed via Sitz marker X-rays. The average CTT was 42·1h for the active period and 43·3h for the control period (mean difference 1·2h, 95% CI-4·9, 7·4). Since the statistical tests for the cross-over study implied that the mean CTT for the active and control periods in period 2 were biased, the standard protocol suggests examining the results of only period 1 as a traditional randomised controlled trial. This showed that the mean CTT was 35·2h for the active period v. 52·9h for the control period (P=0·015). Bootstrapping demonstrated that both the mean and median differences remained significant (P=0·016 and P=0·045, respectively). Few adverse events were noted, with no differences among the active and control periods. The paired analysis showed no differences between the active and control periods during the cross-over trial. Further trials should be conducted in populations with underlying problems associated with disordered transit to determine the potential value of probiotic supplementation more accurately.
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U2 - 10.1017/S0007114513002237
DO - 10.1017/S0007114513002237
M3 - Article
C2 - 24103188
AN - SCOPUS:84896627954
SN - 0007-1145
VL - 111
SP - 279
EP - 286
JO - British Journal of Nutrition
JF - British Journal of Nutrition
IS - 2
ER -