Short-term, daily intake of yogurt containing Bifidobacterium animalis ssp. lactis Bf-6 (LMG 24384) does not affect colonic transit time in women

Abstract

The present study investigated the effect of Bifidobacterium animalis ssp. lactis Bf-6 (LMG 24 384) (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 14 d 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 42·1 h for the active period and 43·3 h for the control period (mean difference 1·2 h, 95 % CI 24·9, 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 35·2 h for the active period v. 52·9 h for the control period (P¼ 0·015). Bootstrapping demonstrated that both the mean and median differences remained significant (P¼ 0·016 and P¼ 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.

Systematic review: probiotics in the management of lower gastrointestinal symptoms – an updated evidence‐based international consensus

“…The third study did not provide a between‐group statistical analysis; however, the decrease in constipation frequency score was approximately twofold greater in the probiotic groups than in the placebo group . Four studies reported no significant effect of 4 different probiotic treatments; however, 1 of these studies showed a nonsignificant trend in favour of probiotics . Of the 7 studies, 5 had been published since the original consensus.…”

“…The majority of the 70 studies (Table S1) focused on IBS (based on Rome I, II or III criteria or physician diagnosis; 34 studies), antibiotic‐associated diarrhoea (13 studies) or diarrhoea‐associated Helicobacter pylori eradication therapy (7 studies). Other conditions were investigated in 16 studies.…”

“…Of these, 1 study (included in the original consensus) investigated abdominal pain as a primary endpoint in individuals with symptoms related to post‐prandial intestinal gas, and found a significant improvement in the probiotic group compared with the placebo group . Seven studies examined abdominal pain as a secondary endpoint only, with 4 of these reporting no significant difference among 4 different probiotic treatments and placebo . Another 3 studies (2 examining 2 different probiotics in lactose‐intolerant individuals and another reporting on a different probiotic in patients with functional GI symptoms) found significantly improved abdominal pain from baseline in the probiotic group, but not in the placebo group.…”

“…Seven studies examined the effect of 7 different probiotics on flatus in indications other than IBS. Four of these studies reported no significant effects on flatus (primary endpoint for 1 probiotic and secondary endpoint for 3 other probiotics). Three studies reported a significant benefit of 3 different probiotic treatments on flatus (secondary endpoint) in women with mild digestive symptoms, patients with functional GI symptoms and individuals with lactose intolerance undergoing a lactose breath test .…”

“…Eleven studies examining 10 different probiotic treatments assessed bowel habit in indications other than IBS. Of these, 8 studies of 8 different probiotics reported that probiotics produced significant improvements in measures of bowel habit vs placebo, whereas 3 reported no difference between 3 different probiotics and placebo . Of the 11 studies, 7 had been published since the original consensus.…”