NCT07408271

The Impact of Helicobacter Pylori Eradication on the Vaginal Microecology Change

The Impact of Rabeprazole-based Triple Therapy Plus Bismuth for First-line Helicobacter Pylori Eradication on the Vaginal Microecology Change: a Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This clinical controlled study enrolled 73 H. pylori（Helicobacter Pylori ）-infected female participants, stratified into reproductive-age and menopausal cohorts, alongside 10 non-infected controls. Through integrated analysis of routine vaginal discharge parameters and longitudinal amplicon sequencing data of vaginal discharge, investigators analyzed the impact of H. pylori eradication therapy on vaginal microecology.

Detailed description

Between April 2023 and December 2024, a clinical investigation evaluating the impact of H. pylori eradication therapy on vaginal microbiota was conducted at the Gastroenterology outpatient clinic of the Second Affiliated Hospital, Zhejiang University School of Medicine. Eligible naive H. pylori infected female participants received rabeprazole-based triple therapy plus bismuth H. pylori eradication therapy: Rabeprazole 10 mg twice a day (Eisai Pharmaceutical Co., Ltd.), Colloidal Bismuth Pectin 220 mg twice a day (Shanxi Ante Biological Pharmaceutical Co., Ltd.), Amoxicillin 1.0 g twice a day (CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.), and Clarithromycin 0.5 g twice a day (Shanghai Abbott Pharmaceutical Co., Ltd.). The course of radical treatment in two groups was 14 days. A reference group of H. pylori non-infected females was concurrently enrolled.. Routine vaginal discharge examinations and longitudinal metagenomic sequencing of vaginal microbiota were performed at four timepoints: pre-therapy baseline (T1), 2-week (T2), 8-week (T3), and 6-month (T4) post-treatment. H. pylori infection status was re-evaluated at T3.

Conditions

• Helicobacter Pylori Infection
• Helicobacter Pylori Eradication Antibiotic

Interventions

Type	Name	Description
DRUG	rabeprazole-based triple therapy plus bismuth H. pylori eradication therapy	rabeprazole-based triple therapy plus bismuth H. pylori eradication therapy: Rabeprazole 10 mg twice a day (Eisai Pharmaceutical Co., Ltd.), Colloidal Bismuth Pectin 220 mg twice a day (Shanxi Ante Biological Pharmaceutical Co., Ltd.), Amoxicillin 1.0 g twice a day (CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.), and Clarithromycin 0.5 g twice a day (Shanghai Abbott Pharmaceutical Co., Ltd.)

Timeline

• Start date: 2023-03-24
• Primary completion: 2023-03-24
• Completion: 2024-03-24
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: China