- 2025-12-26
- Medicine 104(52)
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 113
- Population
- 113 patients diagnosed with functional constipation (following Rome IV criteria)
- Methods
- randomized, double-blind, placebo-controlled trial; BC01 powder 5×10^9 CFU/d vs placebo
- Blinding
- Double-blind
- Duration
- 21 days
Background
Functional constipation is a prevalent gastrointestinal disease that remains challenging to cure. Probiotic is a promising way to treat functional constipation. Weizmannia coagulans BC01, a genetically and phenotypically safe probiotic strain, has the potential ability to improve constipation symptoms.Methods
We mainly investigated the effects of W coagulans BC01 (BC01) in the management of functional constipation and associated gastrointestinal symptoms in a randomized, double-blind, placebo-controlled trial. A total of 113 patients diagnosed with functional constipation (following Rome IV criteria) were randomly divided into BC01 (n = 79; received BC01 powder; 5 × 109 CFU/d) and placebo (n = 34; received placebo material) groups. Constipation symptoms were evaluated by the ROME IV criteria and evacuation diaries. The clinical improvement was evaluated using the Cleveland Scores, the Bristol, and the Gastrointestinal Quality of Life Index. Short-chain fatty acids were detected by reverse transcriptase polymerase chain reaction. Fecal microbiota was analyzed by 16S rRNA gene sequencing.Results
After 21 days of treatment, the values of Bristol and Gastrointestinal Quality of Life Index were significantly increased by BC01 supplementation, and the Cleveland scores was decreased in patients with functional constipation. Besides, the contents of acetic acid and isobutyric acid significantly increased by treated with BC01. The disorder gut microbiota in patients with functional constipation was also reshaped by BC01, resulting in higher abundance of Bacteroides, Bifidobacterium, and Roseburia, and lower abundance of Firmicutes, Proteobacteria, and Blautia. No adverse events were observed throughout the trial period.Conclusion
Current evidence supports the use of BC01 as a therapeutic option for managing functional constipation.