The Impact of Helicobacter Pylori Eradication on the Vaginal Microecology Change

Second Affiliated Hospital, Zhejiang University, School of Medicine83 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Helicobacter Pylori Infection Helicobacter Pylori Eradication Antibiotic

Interventions

rabeprazole-based triple therapy plus bismuth H. pylori eradication therapyDRUG

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.)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria： * Aged 18-70 years, female * H. pylori infected or non-infected * No use of PPIs, H2 receptor antagonists, antibiotics, or bismuth agents within 4 weeks prior * No prior formal H. pylori eradication treatment Exclusion Criteria： * Use of antibiotics or bismuth agents within 4 weeks before treatment, or use of PPIs or H2 receptor antagonists within 2 weeks before treatment * History of gastric or duodenal surgery * Concurrent presence of other severe cardiac, hepatic, or renal insufficiency, malignant tumors, or other serious internal medical diseases * Allergy to any component of the study drugs * Pregnant or lactating women * Participation in other drug clinical trials within 3 months before treatment * Inability to accurately express complaints or cooperate with the study investigators

Locations (1)

Department of Gastroenterology, Second Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

diversity and composition of vaginal microbiota

1.Change in Vaginal Microbiota Diversity (Alpha/Beta) Before and After H. pylori Eradication Therapy；2.Composition of Vaginal Microbiota at the Phylum/Genus Level.

Time frame: baseline (T1, pre-treatment), 2 weeks (T2), 8 weeks (T3), and 6 months (T4) post-therapy

Secondary Outcomes

routine vaginal discharge

Vaginal discharge indicators (pH value, color, cleanliness grade, Lactobacillus abundance, fungus detection, clue cells, white blood cells, epithelial cells, and other bacteria)

Time frame: Routine vaginal discharge examinations were assessed at baseline (T1, pre-treatment) and 8 weeks (T3),

Data from ClinicalTrials.gov

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