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

2025-08
The Journal of infection 91(2)
- Xiaoni Han
- Hui Liu
- Kaige Zhang
- Yuyu Zeng
- Peng Liu
- Lihong Gan
- Li Zheng
- Zhiguo Liu
- Nian Fang
- Tingtao Chen

PubMed: 40545179
DOI: 10.1016/j.jinf.2025.106539

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 257 sexually active, premenopausal women aged 18-50 years, diagnosed with H. pylori infection alongside chronic gastritis
Methods: Randomized, placebo-controlled, 14 days of bismuth-containing quadruple therapy (amoxicillin, furazolidone, potassium bismuth citrate, rabeprazole) combined with either L. plantarum MH-301 or placebo; stool and vaginal samples collected before and after treatment for high-throughput sequencing
Duration: 14 days
Funding: Unclear

Background

Adverse events and microbiota dysbiosis resulting from Helicobacter pylori eradication therapy have become increasingly evident. This study aims to investigate the adjunctive therapeutic effects of Lactiplantibacillus plantarum MH-301 in H. pylori eradication therapy, as well as its effects on the gut and vaginal microbiota.

Method

257 sexually active, premenopausal women aged 18-50 years, diagnosed with H. pylori infection 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 Gardnerella increased. Compared to the placebo group, the probiotic group showed a higher relative abundance of Megamonas, Prevotella, and Lactobacillus in 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 Lactobacillus in both gut and vaginal microbiota (P<0.05).

Conclusion

This study clinically demonstrates for the first time that L. plantarum MH - 301 may reduce H. pylori treatment - related adverse events via gut - vaginal axis. In addition, microbiota modulation may be the mechanism through which it exerts its clinical efficacy.