The Impact of Helicobacter Pylori Eradication on the Vaginal Microecology Change

February 9, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Department of Gastroenterology, Second Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

H. pylori infected female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
H. pylori infection

Inclusion Criteria: 1) Aged 18-70 years, female; 2) H. pylori infected or non-infected; 3) No use of proton pump inhibitors (PPIs), Histamine H2 receptor Antagonists（H2 receptor antagonists), antibiotics, or bismuth agents within 4 weeks prior; 4) No prior formal H. pylori eradication treatment.

Intervention: Eligible naive H. pylori infected female participants received rabeprazole-based triple therapy plus bismuth H. pylori eradication therapy.

Data Collection: Each visit included gynecological evaluation with duplicate vaginal discharge collection for routine examination and metagenomic sequencing.H.pylori status was re-evaluated.
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.)
Other Names:
  • H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline (T1, pre-treatment), 2 weeks (T2), 8 weeks (T3), and 6 months (T4) post-therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Routine vaginal discharge examinations were assessed at baseline (T1, pre-treatment) and 8 weeks (T3),

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2023

Primary Completion (Actual)

March 24, 2023

Study Completion (Actual)

March 24, 2024

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-0172
  • Approval No.: 2023-0282 (Other Identifier: The Second Affiliated Hospital, Zhejiang University School of Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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