Effect of an 8-Week Bifidobacterium lactis HN019 Supplementation on Functional Constipation: A Multi-Center,...

Area of Science:

• Gastroenterology
• Microbiology
• Clinical Nutrition

Background:

• Functional constipation (FC) presents as difficult, infrequent, or incomplete bowel movements without a clear physiological cause.
• Bifidobacterium lactis HN019 (HN019) has previously shown potential in improving bowel regularity.
• The Rome III criteria define the diagnostic standards for functional gastrointestinal disorders, including FC.

Purpose of the Study:

• To evaluate the efficacy of 8-week HN019 supplementation in increasing complete spontaneous bowel movements (CSBMs) in adults with FC.
• To assess secondary outcomes including stool consistency, straining, abdominal pain, bloating, and quality of life.

Main Methods:

• A triple-blind, randomized, placebo-controlled trial involving adults diagnosed with FC.
• Participants received daily HN019 or a placebo for 8 weeks after a 2-week screening period.
• Outcomes measured included CSBM frequency, stool characteristics, symptom severity (PAC-SYM, PAC-QoL), and rescue medication use.

Main Results:

• HN019 supplementation was not superior to placebo in improving the frequency of CSBMs in adults with FC.
• No significant differences were observed between the HN019 and placebo groups for stool consistency, straining, pain, bloating, or quality of life.
• Fecal analyses (microbiota, metabolites, calprotectin) did not reveal significant group differences.

Conclusions:

• This study did not support the use of B. lactis HN019 for improving CSBM frequency in adults with functional constipation.
• HN019 supplementation demonstrated a favorable safety profile, with no adverse events reported.
• Further research may be needed to explore specific probiotic strains or different populations for FC management.