Efficacy of Bifidobacterium animalis subsp. lactis BL-99 in the treatment of functional dyspepsia: a randomized placebo-controlled clinical trial
- Qi Zhang
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- Guang Li
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- Wen Zhao
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- Xifan Wang
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- Jingjing He
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- Limian Zhou
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- Xiaoxu Zhang
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- Peng An
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- Yinghua Liu
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- Chengying Zhang
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- Yong Zhang
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- Simin Liu
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- Liang Zhao
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- Rong Liu
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- Yixuan Li
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- Wenjian Jiang
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- Xiaoyu Wang
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- Qingyu Wang
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- Bing Fang
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- Yuyang Zhao
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- Yimei Ren
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- Xiaokang Niu
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- Dongjie Li
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- Shaoqi Shi
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- Wei-Lian Hung
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- Ran Wang
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- Xinjuan Liu
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- Fazheng Ren
Abstract
Functional dyspepsia (FD) is a common chronic gastrointestinal disorder. Here, in a randomized, parallel-group, positive-drug, and placebo-controlled clinical trial, the authors show that supplementation with the probiotic Bifidobacterium animalis su...
Functional dyspepsia (FD) is a common chronic gastrointestinal disorder. Here, in a randomized, parallel-group, positive-drug, and placebo-controlled clinical trial, the authors show that supplementation with the probiotic Bifidobacterium animalis subsp. lactis BL-99 (BL-99) improves FD clinical response rate and promotes accumulation of SCFA-producing microbiota. 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.