Helicobacter Pylori Eradication Antibiotic, Helicobacter Pylori Infection
Conditions
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.
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.
Interventions
DRUGrabeprazole-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.)
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diversity and composition of vaginal microbiota | 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
| Measure | Time frame | Description |
|---|---|---|
| routine vaginal discharge | 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) |
Countries
China
Outcome results
None listed