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Helicobacter Pylori InfectionNCT07408271

The Impact of Helicobacter Pylori Eradication on the Vaginal Microecology Change

An observational study of Helicobacter Pylori Infection and Helicobacter Pylori Eradication Antibiotic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
What is being tested?
rabeprazole-based triple therapy plus bismuth H. pylori eradication therapy
How many people
83 participants
Where
1 siteChina
Study dates
24 Mar 2023to 24 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: H. pylori infected female

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Hangzhou, Zhejiang

Other trials in China

About this study

Official 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

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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called H. pylori eradication

    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.)

Study groups in NCT07408271
Study groupRoleWhat they receive
H. pylori infectionInclusion 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.
Receives: Drug: rabeprazole-based triple therapy plus bismuth H. pylori eradication therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (1)

  1. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start24 Mar 2023
  3. Primary completion24 Mar 2023
  4. Study completion24 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408271
Sponsor's protocol ID
2023-0172
Other IDs
Approval No.: 2023-0282
Status last verified
Mar 2023
First submitted
27 Jan 2026
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shukla A, Sobel JD. Vulvovaginitis Caused by Candida Species Following Antibiotic Exposure. Curr Infect Dis Rep. 2019 Nov 9;21(11):44. doi: 10.1007/s11908-019-0700-y.

    PubMed 31707496

  • Xu J, Schwartz K, Bartoces M, Monsur J, Severson RK, Sobel JD. Effect of antibiotics on vulvovaginal candidiasis: a MetroNet study. J Am Board Fam Med. 2008 Jul-Aug;21(4):261-8. doi: 10.3122/jabfm.2008.04.070169.

    PubMed 18612052

  • Wang Y, Zhang Z, Chen Q, Chen T. Simultaneous application of oral and intravaginal probiotics for Helicobacter pylori and its antibiotic-therapy-induced vaginal dysbacteriosis. NPJ Biofilms Microbiomes. 2024 Jun 20;10(1):49. doi: 10.1038/s41522-024-00521-9.

    PubMed 38902244

  • Brotman RM. Vaginal microbiome and sexually transmitted infections: an epidemiologic perspective. J Clin Invest. 2011 Dec;121(12):4610-7. doi: 10.1172/JCI57172. Epub 2011 Dec 1.

    PubMed 22133886

  • Tshibangu-Kabamba E, Yamaoka Y. Helicobacter pylori infection and antibiotic resistance - from biology to clinical implications. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):613-629. doi: 10.1038/s41575-021-00449-x. Epub 2021 May 17.

    PubMed 34002081

  • Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

    PubMed 27707777

  • Oh JE, Kim BC, Chang DH, Kwon M, Lee SY, Kang D, Kim JY, Hwang I, Yu JW, Nakae S, Lee HK. Dysbiosis-induced IL-33 contributes to impaired antiviral immunity in the genital mucosa. Proc Natl Acad Sci U S A. 2016 Feb 9;113(6):E762-71. doi: 10.1073/pnas.1518589113. Epub 2016 Jan 25.

    PubMed 26811463

  • Burucoa C, Axon A. Epidemiology of Helicobacter pylori infection. Helicobacter. 2017 Sep;22 Suppl 1. doi: 10.1111/hel.12403.

    PubMed 28891138

  • Wizenty J, Sigal M. Helicobacter pylori, microbiota and gastric cancer - principles of microorganism-driven carcinogenesis. Nat Rev Gastroenterol Hepatol. 2025 May;22(5):296-313. doi: 10.1038/s41575-025-01042-2. Epub 2025 Feb 26.

    PubMed 40011753

Questions about this trial

What is this clinical trial studying?

An observational study of Helicobacter Pylori Infection and Helicobacter Pylori Eradication Antibiotic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diversity and composition of vaginal microbiota (time frame: baseline (T1, pre-treatment), 2 weeks (T2), 8 weeks (T3), and 6 months (T4) post-therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07408271, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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