Lactiplantibacillus plantarum MH-301 reduces Helicobacter pylori treatment-related adverse events via gut-vaginal axis: a randomized, double-blind, placebo-controlled trial

Background: Adverse events and microbiota dysbiosis resulting from Helicobacter pylori eradication therapy have become increasingly evident. This study investigates the adjunctive therapeutic effects of Lactiplantibacillus plantarum MH-301 in H. pylori eradication therapy, along with its effects on the gut and vaginal microbiota. Method: 257 sexually active, premenopausal women aged 18-50 years, diagnosed with H. pyloriinfection alongside chronic gastritis, were randomly allocated to undergo either bismuth-containing quadruple therapy (amoxicillin, furazolidone, potassium bismuth citrate, rabeprazole) combined with probiotics (L. plantarum MH-301) or a placebo for 14 days. Stool samples and vaginal swabs were collected before and after treatment to facilitate high-throughput sequencing analysis. Result: The probiotic group exhibited lower incidences of bloating (10.2% vs 19.4%, P=0.037), constipation (2.3% vs 7.8%, P =0.048), and excessive vaginal discharge (3.1% vs 9.3%, P=0.040), and showed better treatment tolerability compared to the placebo group (P<0.05), although no statistically significant difference in eradication rates between the two groups. High-throughput sequencing revealed that H. pylori eradication therapy led to a decrease in the relative abundance of Prevotella in the gut microbiota, and an increase in Streptococcus and Haemophilus. In the vaginal microbiota, Lactobacillus decreased while Gardnerellaincreased. Compared to the placebo group, the probiotic group showed a higher relative abundance of Megamonas, Prevotella, and Lactobacillusin the gut microbiota, and lower levels of Streptococcus and Haemophilus. In the vaginal microbiota, Gardnerella was significantly lower (P<0.05). Correlation analysis revealed a positive association between gastrointestinal and vaginal adverse events, and a positive correlation of Lactobacillusin both gut and vaginal microbiota (P<0.05). Conclusion: This study is the first to demonstrate at the clinical level that L. plantarumMH-301 reduces H. pylori treatment-related adverse events via gut-vaginal axis. In addition, microbiota modulation could be the possible mechanism through which it achieves its clinical efficacy.