Eight-Week Supplementation With Bifidobacterium lactis HN019 and Functional Constipation: A Randomized Clinical Trial

Area of Science:

• Gastroenterology
• Microbiology
• Clinical Nutrition

Background:

• Probiotic supplementation is often suggested to improve bowel movements.
• However, robust clinical evidence from large-scale, well-designed studies is limited.
• Functional constipation affects a significant portion of the population, necessitating effective interventions.

Purpose of the Study:

• To assess the efficacy of Bifidobacterium animalis subsp lactis HN019 in improving complete spontaneous bowel movements (CSBMs) in individuals with functional constipation.
• To evaluate the impact of this probiotic on various secondary outcomes related to bowel function and gut health.
• To provide high-quality evidence regarding probiotic use for constipation management.

Main Methods:

• A randomized, triple-blind, placebo-controlled trial involving 229 participants with functional constipation.
• Participants received either Bifidobacterium animalis subsp lactis HN019 or a maltodextrin placebo daily for 8 weeks.
• Primary outcome was the change in weekly CSBMs; secondary outcomes included stool consistency, abdominal pain, bloating, and fecal analyses.

Main Results:

• No significant difference was observed in the change of weekly CSBMs from baseline between the HN019 group and the placebo group.
• Secondary outcomes such as stool consistency, straining, abdominal pain, and bloating also showed no significant improvements with probiotic intervention.
• Fecal analyses did not reveal significant alterations in microbiota composition or other measured parameters between groups.

Conclusions:

• Daily consumption of Bifidobacterium animalis subsp lactis HN019 at a dose of 4.69 × 10^9 CFU did not demonstrate superior efficacy over placebo in increasing CSBMs.
• This large, well-conducted clinical trial does not support the use of this specific probiotic for improving bowel movements in functional constipation.
• The findings highlight the need for continued rigorous research into the role of probiotics in managing constipation.