NCT07408271

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

January 27, 2026

Last Update Submit

February 9, 2026

Conditions

Helicobacter Pylori InfectionHelicobacter Pylori Eradication Antibiotic

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • routine vaginal discharge

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

Study Arms (1)

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

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.)

Also known as: H. pylori eradication
H. pylori infection

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

H. pylori infected female

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

Related Publications (9)

  • 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.

    PMID: 31707496BACKGROUND

  • 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.

    PMID: 18612052BACKGROUND

  • 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.

    PMID: 38902244BACKGROUND

  • 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.

    PMID: 22133886BACKGROUND

  • 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.

    PMID: 34002081BACKGROUND

  • 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.

    PMID: 27707777BACKGROUND

  • 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.

    PMID: 26811463BACKGROUND

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

    PMID: 28891138BACKGROUND

  • 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.

    PMID: 40011753BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 13, 2026

Study Start

March 24, 2023

Primary Completion

March 24, 2023

Study Completion

March 24, 2024

Last Updated

February 13, 2026

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)