Efficacy and safety of live combined Bacillus subtilis and Enterococcus faecium in patients with Helicobacter pylori infection: A meta-analysis of randomized controlled trials.

OBJECTIVE: Live Combined Bacillus subtilis and Enterococcus faecium (LCBE) regulates gut microbiota and gastrointestinal inflammation. This meta-analysis aimed to compare the efficacy and safety of interventions with or without LCBE in patients with Helicobacter pylori (H. pylori) infection. METHODS: Web of Science, PubMed, Cochrane Library, China National Knowledge Infrastructure, Wan Fang and China Science and Technology Journal Database were searched until February 2025. Patients with H. pylori infection receiving interventions with or without LCBE were assigned to the experimental and control groups, respectively. This meta-analysis was retrospectively registered in PROSPERO (CRD420261430266). RESULTS: A total of 26 randomized controlled trials containing 3,536 patients with H. pylori infection were included. H. pylori eradication rate in the experimental group was 2.403-times of that in the control group. The total adverse event rate in the experimental group was 0.329-times of that in the control group. Diarrhea rate, nausea and vomiting rate, abdominal distension rate, poor appetite rate and constipation rate were lower in the experimental group than those of the control group. With regard to non-gastrointestinal adverse events, only taste disorder rate was lower in the experimental group than that of the control group. The expression levels of immunoglobulins A and G were increased, while those of tumor necrosis factor-alpha and interleukin-6 were decreased in the experimental group compared with those noted in the control group. CONCLUSION: LCBE-containing interventions are associated with higher eradication rates, fewer adverse events, and favorable changes in immune and inflammatory markers in patients with H. pylori infection.