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

Author

Listed:
  • 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)

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.

Suggested Citation

  • 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 , 2024. "Efficacy of Bifidobacterium animalis subsp. lactis BL-99 in the treatment of functional dyspepsia: a randomized placebo-controlled clinical trial," Nature Communications, Nature, vol. 15(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-023-44292-x
    DOI: 10.1038/s41467-023-44292-x
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    References listed on IDEAS

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    1. Rachel J. Perry & Liang Peng & Natasha A. Barry & Gary W. Cline & Dongyan Zhang & Rebecca L. Cardone & Kitt Falk Petersen & Richard G. Kibbey & Andrew L. Goodman & Gerald I. Shulman, 2016. "Acetate mediates a microbiome–brain–β-cell axis to promote metabolic syndrome," Nature, Nature, vol. 534(7606), pages 213-217, June.
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