Efficacy of Bifidobacterium animalis subsp. lactis BL-99 in the treatment of functional dyspepsia: a randomized placebo-controlled clinical trial

Qi Zhang, Guang Li, Wen Zhao, Xifan Wang, Jingjing He, Limian Zhou, Xiaoxu Zhang, Peng An, Yinghua Liu, Chengying Zhang, Yong Zhang, Simin Liu, Liang Zhao, Rong Liu, Yixuan Li, Wenjian Jiang, Xiaoyu Wang, Qingyu Wang, Bing Fang, Yuyang Zhao, Yimei Ren, Xiaokang Niu, Dongjie Li, Shaoqi Shi, Wei-Lian Hung (), Ran Wang (), Xinjuan Liu () and Fazheng Ren ()
Additional contact information
Qi Zhang: China Agricultural University
Guang Li: Capital Medical University
Wen Zhao: China Agricultural University
Xifan Wang: Columbia University
Jingjing He: China Agricultural University
Limian Zhou: Hefei University of Technology
Xiaoxu Zhang: China Agricultural University
Peng An: China Agricultural University
Yinghua Liu: Chinese PLA General Hospital
Chengying Zhang: The Third Medical Center of Chinese PLA General Hospital
Yong Zhang: Chinese PLA General Hospital
Simin Liu: Brown University
Liang Zhao: China Agricultural University
Rong Liu: China Agricultural University
Yixuan Li: China Agricultural University
Wenjian Jiang: Capital Medical University
Xiaoyu Wang: China Agricultural University
Qingyu Wang: Beijing Hospital/National Center of Gerontology of National Health Commission
Bing Fang: China Agricultural University
Yuyang Zhao: China Agricultural University
Yimei Ren: China Agricultural University
Xiaokang Niu: China Agricultural University
Dongjie Li: Capital Medical University
Shaoqi Shi: China Agricultural University
Wei-Lian Hung: Inner Mongolia Dairy Technology Research Institute Co. Ltd.
Ran Wang: China Agricultural University
Xinjuan Liu: Capital Medical University
Fazheng Ren: China Agricultural University

Nature Communications, 2024, vol. 15, issue 1, 1-12

Abstract: Abstract Current treatment for functional dyspepsia (FD) has limited and unsustainable efficacy. Probiotics have the sustainable potential to alleviate FD. This randomized controlled clinical trial (Chinese Clinical Trial Registry, ChiCTR2000041430) assigned 200 FD patients to receive placebo, positive-drug (rabeprazole), or Bifidobacterium animalis subsp. lactis BL-99 (BL-99; low, high doses) for 8-week. The primary outcome was the clinical response rate (CRR) of FD score after 8-week treatment. The secondary outcomes were CRR of FD score at other periods, and PDS, EPS, serum indicators, fecal microbiota and metabolites. The CRR in FD score for the BL-99_high group [45 (90.0%)] was significantly higher than that for placebo [29 (58.0%), p = 0.001], BL-99_low [37 (74.0%), p = 0.044] and positive_control [35 (70.0%), p = 0.017] groups after 8-week treatment. This effect was sustained until 2-week after treatment but disappeared 8-week after treatment. Further metagenomic and metabolomics revealed that BL-99 promoted the accumulation of SCFA-producing microbiota and the increase of SCFA levels in stool and serum, which may account for the increase of serum gastrin level. This study supports the potential use of BL-99 for the treatment of FD.

Date: 2024
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DOI: 10.1038/s41467-023-44292-x

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