Bifidobacterium animalis subsp. lactis HN019 (HN019) improves chronic idiopathic constipation. Our objective was to determine the efficacy and safety of supplementing with 1 × 10^9 or 1 × 10^10 CFU HN019/day for 28 days in the treatment of constipation. A total of 228 adults diagnosed with functional constipation according to the Rome III criteria were randomized in a double-blind, placebo-controlled trial.
Colonic transit time (CTT), the primary outcome, and secondary outcomes—including the Patient Assessment of Constipation Symptoms (PAC-SYM), the Patient Assessment of Constipation Quality of Life (PAC-QoL), the Bowel Function Index (BFI), bowel movement frequency (BMF), stool consistency, straining, bowel emptying, bloating, and pain severity—were assessed.
Additional parameters and adverse events (AEs) were also evaluated. No statistically significant differences were observed in the primary or secondary outcomes between interventions. Post-hoc analysis of 65 participants with fewer than 3 bowel movements per week (BMF ≤ 3/week) showed a physiologically relevant increase in weekly BMF in both the high-dose HN019 group (+2.0) and the low-dose group (+1.7). According to RMANOVA, when combined, HN019 groups with BMF ≤ 3/week had a higher BMF compared with placebo (P = 0.01). Thus, improving infrequent bowel movements may be a target for future interventions with HN019. High-dose HN019 also reduced straining on Day 28 compared with placebo in those with BMF ≤ 3/week (P = 0.02).
Three unrelated AEs—two in the low-dose HN019 group and one in the placebo group—were monitored until full recovery. In summary, although no differences were found in the primary analysis, HN019 was well tolerated and improved BMF in adults with infrequent bowel movements.
Objective: To evaluate the beneficial effects of Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation.
Study design: A randomized, double-blind, placebo-controlled study was conducted from January 2008 to December 2008 in 44 consecutive infants at least 6 months of age (mean age ± SD, 8.2 ± 2.4 months; male/female, 24/20) admitted to the Endoscopy and Gastrointestinal Motility Unit, Department of Pediatrics, “Federico II” University, Naples, with a diagnosis of functional chronic constipation. The 44 infants were randomized into two groups: Group A (n = 22) received probiotic L. reuteri (DSM 17938), and Group B (n = 22) received an identical placebo. Primary outcome measures included weekly bowel movement frequency, stool consistency, and inconsolable crying episodes, recorded daily by parents in a diary.
Results: Infants receiving L. reuteri (DSM 17938) had significantly higher bowel movement frequency compared with those receiving placebo at week 2 (P = 0.042), week 4 (P = 0.008), and week 8 (P = 0.027) after supplementation. In the L. reuteri group, stool consistency was reported as hard in 19 infants (86.4%) at baseline, 11 infants (50%) at week 2, and 4 infants (18.2%) at both week 4 and week 8. However, no significant differences were observed between the L. reuteri and placebo groups for stool consistency at any time point (P = 0.63, week 2; P = 0.38, week 4; P = 0.48, week 8). Similarly, there were no statistically significant differences between groups regarding inconsolable crying episodes. No adverse effects were reported.
Conclusion: The use of L. reuteri (DSM 17938) in infants with chronic constipation had a positive effect on bowel movement frequency, even though no improvements were seen in stool consistency or persistent crying episodes. Given its safety profile, the probiotic may be an attractive option in the treatment of functional constipation.
