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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- diversity and composition of vaginal microbiota
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: rabeprazole-based triple therapy plus bismuth H. pylori eradication therapy (Drug)
结局指标
主要结局
diversity and composition of vaginal microbiota
时间窗: 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.
次要结局
- routine vaginal discharge(Routine vaginal discharge examinations were assessed at baseline (T1, pre-treatment) and 8 weeks (T3),)