Dietary Supplements

Weizmannia coagulans BC01 supplementation improved functional constipation by regulating gut microbiota: A randomized, placebo-controlled, clinical study.

TL;DR

Weizmannia coagulans BC01 supplementation (5×10⁹ CFU/d for 21 days) significantly improved functional constipation symptoms, quality of life, and gut microbiota composition compared to placebo in a randomized, double-blind, placebo-controlled trial.

Key Findings

BC01 supplementation significantly improved stool consistency as measured by the Bristol Stool Scale after 21 days of treatment.

  • 113 patients with functional constipation (Rome IV criteria) were randomized to BC01 (n=79) or placebo (n=34) groups
  • BC01 group received 5×10⁹ CFU/d for 21 days
  • Bristol Stool Scale values were 'significantly increased by BC01 supplementation'
  • Treatment duration was 21 days

BC01 supplementation significantly improved gastrointestinal quality of life as measured by the Gastrointestinal Quality of Life Index (GIQLI).

  • GIQLI values were 'significantly increased by BC01 supplementation' after 21 days
  • The BC01 group consisted of 79 patients receiving 5×10⁹ CFU/d
  • Compared against placebo group of 34 patients
  • The trial was double-blind and placebo-controlled

BC01 supplementation significantly reduced constipation severity as measured by the Cleveland Constipation Score.

  • Cleveland Scores were 'decreased in patients with functional constipation' following BC01 treatment
  • Reduction observed after 21 days of treatment at 5×10⁹ CFU/d
  • Cleveland Score, Bristol Scale, and GIQLI were used as primary clinical outcome measures
  • Constipation symptoms were also evaluated using ROME IV criteria and evacuation diaries

BC01 supplementation significantly increased fecal short-chain fatty acid concentrations, specifically acetic acid and isobutyric acid.

  • The contents of acetic acid and isobutyric acid 'significantly increased' with BC01 treatment
  • Short-chain fatty acids were detected by reverse transcriptase polymerase chain reaction
  • Changes were observed after 21 days of treatment
  • Other short-chain fatty acids were measured but acetic acid and isobutyric acid showed significant changes

BC01 supplementation reshaped disordered gut microbiota in functional constipation patients, increasing beneficial bacteria and decreasing potentially harmful taxa.

  • BC01 treatment resulted in 'higher abundance of Bacteroides, Bifidobacterium, and Roseburia'
  • BC01 treatment resulted in 'lower abundance of Firmicutes, Proteobacteria, and Blautia'
  • Gut microbiota was analyzed by 16S rRNA gene sequencing
  • Changes were observed after 21 days of treatment at 5×10⁹ CFU/d

No adverse events were observed throughout the trial period in either the BC01 or placebo groups.

  • 'No adverse events were observed throughout the trial period'
  • The trial enrolled 113 patients total (BC01 n=79, placebo n=34)
  • Treatment lasted 21 days at 5×10⁹ CFU/d
  • W. coagulans BC01 is described as 'a genetically and phenotypically safe probiotic strain'

The study used a randomized, double-blind, placebo-controlled design with patients diagnosed using Rome IV criteria for functional constipation.

  • 113 patients total were enrolled and randomly divided into BC01 (n=79) and placebo (n=34) groups
  • Diagnosis followed Rome IV criteria for functional constipation
  • BC01 group received BC01 powder at 5×10⁹ CFU/d; placebo group received placebo material
  • Clinical improvement was evaluated using Cleveland Scores, Bristol Scale, and GIQLI
  • Evacuation diaries were also used to track constipation symptoms

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Citation

Xu Y, Zhang Y, Yue F, Yu X, Chen Y, Ma X. (2025). Weizmannia coagulans BC01 supplementation improved functional constipation by regulating gut microbiota: A randomized, placebo-controlled, clinical study.. Medicine. https://doi.org/10.1097/MD.0000000000046861