CompletedNot Applicable

The Impact of Helicobacter Pylori Eradication on the Vaginal Microecology Change

China83 participantsStarted 2023-03-24

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

diversity and composition of vaginal microbiota

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

Trial details

NCT IDNCT07408271

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-24

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials