Bifidobacterium lactis HN019 for constipation
Trial question
What is the role of Bifidobacterium lactis HN019 supplementation in patients with functional constipation?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
85.0% female
15.0% male
N = 229
229 patients (194 female, 35 male).
Inclusion criteria: healthy patients aged 18-70 years with functional constipation according to Rome III criteria.
Key exclusion criteria: constipation-dominated IBS; BMI > 30; age < 18 or > 70 years.
Interventions
N=112 B. lactis HN019 (Bifidobacterium lactis HN019 taken once daily for 8 weeks).
N=117 placebo (maltodextrin taken once daily for 8 weeks).
Primary outcome
Least-square mean improvement in complete spontaneous bowel movements at week 8
-0.8
-0.66
0.0 episodes
-0.2 episodes
-0.4 episodes
-0.6 episodes
-0.8 episodes
B. lactis
HN019
Placebo
No significant
difference ↔
No significant difference in least-square mean improvement in complete spontaneous bowel movements at week 8 (-0.8 episodes vs. -0.66 episodes; MD -0.14, 95% CI -0.45 to 0.17).
Secondary outcomes
No significant difference in least-square mean reduction in stool consistency at week 8 (-0.2 points vs. -0.54 points; MD 0.335, 95% CI -0.04 to 0.71).
Significantly greater reduction in least-square mean abdominal pain at week 8 (0.04 points vs. -1.42 points; MD 1.46, 95% CI 0.07 to 2.84).
Significantly greater reduction in least-square mean bloating at week 8 (0.52 points vs. -2.13 points; MD 2.64, 95% CI 0.36 to 4.92).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In healthy patients aged 18-70 years with functional constipation according to Rome III criteria, B. lactis HN019 was not superior to placebo with respect to a least-square mean improvement in complete spontaneous bowel movements at week 8.
Reference
Jing Cheng, Carl Gao, Reeta Ala-Jaakkola et al. Eight-Week Supplementation With Bifidobacterium lactis HN019 and Functional Constipation: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2436888.
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