Baseline gut microbiome impacts probiotics Bacillus licheniformis CMCC63516 in modulating the gut microbiome and preventing antibiotic‐associated diarrhea: A double‐blind, randomized controlled trial
Abstract
Dear Editor, Here, we report that baseline gut microbiome (GM) associate with the protection of probiotics against pediatric antibiotic-associated diarrhea (AAD) via the double-blind randomized control trial (RCT). Antibiotics are widely prescribed drugs in infancy and childhood.1 Nevertheless, it may result in various adverse events such as AAD. Given the association of AAD with antibiotics-induced GM changes,2,3 recent studies demonstrated the protective role of probiotics in preventing pediatric AAD.3–6 Nevertheless, there is no double-blind RCT to assess the role of probiotics in AAD prevention for Chinese children. This study aimed to evaluate the protective effects of probiotics on pediatric AAD in China, based on multi-center and double-blind RCT (documented at www.chictr.org.cn under the accession number ChiCTRIPR-16009033). In addition, we analyzed GM dynamics in response to antibiotics exposure and probiotics supplementation. The selected probiotics was Zhengchangsheng (Bacillus Licheniformis CMCC63516), which is a grampositive bacterium developed in China and has been proven effective in treatment of diarrhea.6 The inpatients with lower respiratory infections received antibiotic therapy for seven days, and B. licheniformis CMCC63516 (Group B) or placebo (Group P) was randomly administered (Supplementary File 1). Of 218 recruited patients, 173 children completed the trial (Group B, n = 87; Group P, n = 86) (Figure 1), and no adverse advents were reported. The AAD…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 218 participants or records.
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