Efficacy of Bifidobacterium animalis subsp. lactis BL-99 in the treatment of functional dyspepsia: a randomized placebo-controlled clinical trial
What this study found
High-dose BL-99 improved functional dyspepsia symptoms more than placebo and the proton pump inhibitor after 8 weeks, and the benefit persisted for 2 weeks after treatment stopped. The 8-week complete response rate for FD score was 90.0% with BL-99_high versus 58.0% with placebo, 74.0% with BL-99_low, and 70.0% with positive control (p = 0.001, p = 0.044, and p = 0.017, respectively). At 2-week follow-up, the complete response rate remained higher with BL-99_high (84.0%) than placebo (62.0%) and positive control (66.0%) (p = 0.016 and p = 0.041). Serum gastrin G17 increased more with…
- Study & population
- Randomized, placebo-controlled trial in adults 18-60 years with functional dyspepsia diagnosed by Rome IV criteria and no organic lesions on recent upper endoscopy.
- Intervention
- Bifidobacterium animalis subsp.
- Key limitation
- The trial was short, with follow-up limited to 2 weeks after stopping treatment, and the overview notes that benefit did not persist at 8 weeks post-treatment.
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Open PDFOriginal 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 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.