Effects of 28-Day Bifidobacterium animalis subsp. lactis HN019 Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation

Abstract

Introduction:Bifidobacterium animalis subsp. lactis HN019 (HN019) reduces colonic transit time (CTT). Our aim was to study the efficacy and safety of 28-day supplementation with 1x109 or 1x1010 CFU of HN019/day for constipation. Methods: 228 adults diagnosed with functional constipation according to Rome III criteria were randomized in a double-blind and placebo-controlled trial. CTT, the primary outcome, and other outcomes measured using inventories— Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC-QoL), Bowel Function Index (BFI), bowel movement frequency (BMF), stool consistency, degree of straining, bowel emptying, bloating, and pain severity— were assessed. Ancillary parameters and harms were also evaluated. Results: All treatments, including placebo, ameliorated constipation after 28 days. There were no differences between treatments, except for a reduction in PAC-SYM Rectal Symptom Score with the placebo versus the high dose of HN019 at Day 28, possibly due to an artifact. The use of Rome III as the sole criterion for inclusion created discrepancies with the information from the inventories. By post hoc RMANOVA of 65 participants with fewer than 3 bowel movements per week (BMF ≤ 3/week), the HN019 groups, pooled together, experienced greater BMF versus placebo (P value=0.01). Highdose HN019 also decreased degree of straining at Day 28 versus placebo in those with BMF ≤ 3/week (P value=0.02). Three unlikely related AEs—2 with low-dose HN019 and 1 with placebo—were followed until a full recovery. Conclusion: Rome III classification, as the sole criterion for inclusion in clinical research, creates discrepancies in the diagnosis. In conclusion, HN019 is well tolerated and improves BMF in adults with low stool frequency.