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Abstract

Bifidobacterium animalis subsp. lactis HN019 (HN019) ameliorates chronic idiopathic constipation. Our aim was to determine the efficacy and safety of 28-day supplementation with 1 × 109 or 1 × 1010 CFU of HN019/day for constipation. A total of 228 adults who were diagnosed with functional constipation according to the Rome III criteria were randomized in a double-blind and placebo-controlled trial. Colonic transit time (CTT), the primary outcome, and secondary outcomes that were measured using inventories-patient assessment of constipation symptoms (PAC-SYM) and 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. There were no statistically significant differences in the primary or secondary outcomes between interventions. A 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 the high- (+2.0) and low-dose (+1.7) HN019 groups-by RMANOVA, the HN019 groups with BMF ≤ 3/week, pooled together, had a higher BMF versus placebo (P value = 0.01). Thus, improving low stool frequency could be a target of future interventions with HN019. High-dose HN019 also decreased the 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 full recovery. In conclusion, although there were no differences in the primary analysis, HN019 is well tolerated and improves BMF in adults with low stool frequency.

Keywords: Bifidobacterium animalis subsp. lactis HN019; Rome III criteria; bowel movement frequency; functional constipation; probiotic.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium animalisImproved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium animalisReduced StrainingBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420Good TolerabilityNeutral
Moderate
Bifidobacterium animalis subsp. lactis B420Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420Reduced StrainingBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BLC1Increased Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BLC1Reduced StrainingBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Reduced StrainingBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Increased Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Reduced StrainingBeneficial
Moderate
Bifidobacterium animalis subsp. lactis HN019Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium animalis subsp. lactis HN019Reduced StrainingBeneficial
Moderate
Bifidobacterium animalis subsp. lactis LAFTI B94Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium animalis subsp. lactis LAFTI B94Reduced StrainingBeneficial
Moderate
Bifidobacterium animalis subsp. lactis VK2Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium animalis subsp. lactis VK2Reduced StrainingBeneficial
Moderate
Bifidobacterium bifidum BB01Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium bifidum BB01Reduced StrainingBeneficial
Moderate
Bifidobacterium lactisImproved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactisReduced StrainingBeneficial
Moderate
Bifidobacterium lactis B420Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis B420Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis BI-04Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis BI-04Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis Bi-07Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis Bi-07Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis BL818Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis BL818Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis BLA80Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis BLA80Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis BLC-1Increased Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis BLC-1Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis BS01Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis BS01Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis DSM 15954Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis DSM 15954Improved General ToleranceNeutral
Small
Bifidobacterium lactis DSM 15954Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis HA-194Few Adverse EffectsNeutral
Small
Bifidobacterium lactis HA-194Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis HA-194Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis HN019Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis HN019Improved Tolerability of Bifidobacterium lactis HN019Neutral
Small
Bifidobacterium lactis HN019Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis ISS BifGood TolerabilityNeutral
Moderate
Bifidobacterium lactis ISS BifImproved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis ISS BifReduced StrainingBeneficial
Moderate
Bifidobacterium lactis MAK16B42LImproved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis MAK16B42LReduced StrainingBeneficial
Moderate
Bifidobacterium lactis R101-8Increased Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis R101-8Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis SD-5219Improved Bowel Movement FrequencyBeneficial
Moderate
Bifidobacterium lactis SD-5219Improved ToleranceBeneficial
Small
Bifidobacterium lactis SD-5219Reduced StrainingBeneficial
Moderate
Bifidobacterium lactis VK2Improved Gastrointestinal ToleranceBeneficial
Small
Bifidobacterium lactis VK2Increased Bowel Movement FrequencyBeneficial
Moderate

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