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NCT Number: NCT07408271

The Impact of Helicobacter Pylori Eradication on the Vaginal Microecology Change

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.

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Key information

Conditions

Helicobacter Pylori Infection Helicobacter Pylori Eradication Antibiotic

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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.)

Other names: H. pylori eradication

Primary outcomes

  1. diversity and composition of vaginal microbiota

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

    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.

Secondary outcomes

  1. routine vaginal discharge

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

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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