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| ID | Type | Description | Link |
|---|---|---|---|
| Approval No.: 2023-0282 | Other Identifier | The Second Affiliated Hospital, Zhejiang University School of Medicine |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabeprazole-based triple therapy plus bismuth H. pylori eradication therapy | Drug | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| diversity and composition of vaginal microbiota | 1.Change in Vaginal Microbiota Diversity (Alpha/Beta) Before and After H. pylori Eradication Therapyï¼›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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Routine vaginal discharge examinations were assessed at baseline (T1, pre-treatment) and 8 weeks (T3), |
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Inclusion Criteria:
Exclusion Criteria:
Female.
H. pylori infected female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Second Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31707496 | Background | 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. | |
| 18612052 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2023 | Feb 7, 2026 |
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| 38902244 | Background | 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. |
| 22133886 | Background | 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. |
| 34002081 | Background | 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. |
| 27707777 | Background | 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. |
| 26811463 | Background | 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. |
| 28891138 | Background | Burucoa C, Axon A. Epidemiology of Helicobacter pylori infection. Helicobacter. 2017 Sep;22 Suppl 1. doi: 10.1111/hel.12403. |
| 40011753 | Background | 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. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2023 | Feb 4, 2026 | ICF_001.pdf |