Effect of an 8-Week Bifidobacterium lactis HN019 Supplementation on Functional Constipation: A Multi-Center, Triple-Blind, Randomized, Placebo-Controlled Trial.

2025-05-05
Molecular nutrition & food research 69(17)
- Reeta Ala-Jaakkola
- Sofia D Forssten
- Jing Cheng
- Flavie Griffon
- Isabelle Metreau
- Yves Sturm
- Jean-Michel Lecerf
- Yves Donazzolo
- Jouni Junnila
- Anders Nordlund
- Ashley Hibberd
- Arthur C Ouwehand
- Alvin Ibarra

PubMed: 40320938
DOI: 10.1002/mnfr.70081

Study Design

Type: Randomized Controlled Trial (RCT)
Population: adults with FC (diagnosed by Rome III criteria)
Methods: This triple-blind, randomized, placebo-controlled clinical trial assessed the effect of 8 weeks HN019 supplementation; participants at four clinical units in France underwent a 2-week screening followed by an 8-week intervention with daily supplementation of HN019 or placebo.

Functional constipation (FC) is characterized by difficult, infrequent, or incomplete bowel movements without clear physiological cause. Daily intake of Bifidobacterium lactis HN019 has been shown to reduce colonic transit time or increases bowel movement frequency in 2-4 weeks interventions. This triple-blind, randomized, placebo-controlled clinical trial assessed the effect of 8 weeks HN019 supplementation on complete spontaneous bowel movement (CSBMs) in adults with FC (diagnosed by Rome III criteria). Furthermore, stool consistency, degree of straining, abdominal pain severity, bloating severity, PAC-SYM, PAC-QoL, and use of rescue medication were assessed. Participants were screened at four clinical units in France for 2 weeks to confirm eligibility: no safety concerns, ≤3 CSBMs/week (recorded in daily diaries), followed by an 8-week intervention with daily supplementation of HN019 or placebo. HN019 was not found to be superior in managing FC compared to placebo. Fecal samples were collected from 50% of the participants for analyses of moisture content, microbiota, microbial metabolites, and calprotectin. These did not show any significant differences between the groups. This study did not support the expected effect of HN019 on improving CSBM frequency in participants with FC. No safety concerns related to B. lactis HN019 supplementation were identified. Trial Registration: ClinicalTrial.gov: NCT04231162.

Research Insights

Bifidobacterium lactis→Adverse Events
No safety concerns related to B. lactis HN019 supplementation were identified.
Effect
Neutral
Effect size
Small
Bifidobacterium lactis→Improved Functional Constipation
HN019 was not found to be superior in managing FC compared to placebo... This study did not support the expected effect of HN019 on improving CSBM frequency in participants with FC.
Effect
Neutral
Effect size
Small
Bifidobacterium lactis HN019→Improved Bowel Movement Frequency
HN019 was not found to be superior in managing FC compared to placebo.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Improved PAC-QoL Score
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Improved PAC-SYM Score
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Improved Safety Profile
No safety concerns related to B. lactis HN019 supplementation were identified.
Effect
Beneficial
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Improved Stool Consistency
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Increased Fecal Moisture Content
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Reduced Abdominal Pain
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Reduced Fecal Calprotectin Level
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Reduced Flatulence
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Reduced Severity of Gastrointestinal Disorders
stool consistency, degree of straining, abdominal pain severity, bloating severity, PAC-SYM, PAC-QoL, and use of rescue medication were assessed... This study did not support the expected effect of HN019 on improving CSBM frequency in participants with FC.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Reduced Straining
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation
Bifidobacterium lactis HN019→Reduced Use of Rescue Medication
These did not show any significant differences between the groups.
Effect
Neutral
Effect size
Small
Dose
daily supplementation

Adverse Events Reported

Bifidobacterium lactis HN019→Overall tolerability
No safety concerns related to B. lactis HN019 supplementation were identified.
Finding
Reported