Probiotics alleviate oral microbiota disruptions induced by Helicobacter pylori eradication with vonoprazan-amoxicillin dual therapy: a randomized double-blind placebo-controlled trial. (An exploratory study).

BACKGROUND

Helicobacter pylori (H. pylori) infection affects approximately half of the global population and has been linked to oral microbiota dysbiosis, while eradication therapies may further disrupt microbial balance. This exploratory study investigated the effects of H. pylori infection, 14-day vonoprazan-amoxicillin (VA) dual therapy, and adjunctive probiotics (live combined Bacillus subtilis-Enterococcus faecium enteric-coated capsules) on oral microbiota.

METHODS

A total of 78 H. pylori-positive patients were randomized to the PT group (VA + probiotics) or VA group (VA + placebo), with 20 H. pylori-negative volunteers as controls. Tongue coating samples were collected at baseline (W0), post-treatment (W2), and follow-up (W6) for 16S rRNA sequencing.

RESULTS

Results showed that H. pylori infection significantly reduced oral microbial diversity (Chao1 and Shannon indices) and altered community structure (β-diversity) compared to controls, with decreased Hemophilus and Prevotella and impaired carbohydrate metabolic pathways. The 14-day VA regimen transiently reduced α-diversity (Chao1 index) and perturbed β-diversity, with increased Actinobacteria and decreased Bacteroidetes at W2, followed by partial recovery by W6. Notably, the PT group exhibited smaller diversity fluctuations, stable β-diversity, and partially mitigate phylum-level perturbations compared to the VA group, alongside suppressed pathogenic genera (e.g.,Fusobacterium, Mycoplasma) and enhanced carbohydrate metabolism pathways. However, multiple diversity metrics and compositional profiles in both intervention groups remained significantly different from the H. pylori-negative control group at post-treatment (W2) and follow-up (W6) time points.

CONCLUSION

In conclusion, H. pylori infection disrupts oral microbiota, and 14-day VA therapy induces transient microbial perturbations. Adjunctive probiotics partially mitigate these disruptions, supporting oral microecological stability during eradication therapy, but do not achieve full restoration of microbiota balance to the level of uninfected individuals in the short term. These effects are partial, as complete restoration to uninfected microbiota levels was not achieved within the study follow-up period.Chinese Clinical Trial Registry (ChiCTR2400082446).