Differences in the Eradication of Helicobacter Pylori by Different Therapies
Comparison of Vonoprazan Fumarate-based Triple Therapy Versus Proton Pump Inhibitor and Bismuth Based Quadruple Therapy in the Eradication of Helicobacter Pylori: a Single-center Prospective Open-label Controlled Study
1 other identifier
interventional
100
1 country
1
Brief Summary
To compare the performance of four treatment regimens for radical treatment of Helicobacter pylori, evaluating the efficacy, safety, patient compliance, and socioeconomic evaluation of the four regimens. The four treatment regimens included (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2021
CompletedFirst Submitted
Initial submission to the registry
October 16, 2021
CompletedFirst Posted
Study publicly available on registry
October 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2022
CompletedFebruary 18, 2022
February 1, 2022
1 year
October 16, 2021
February 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Eradication rate of Hp at one time
The UBT test was performed to determine whether Hp was eradicated. No antibiotics, bismuth, or PPI were taken during this period. ITT analysis and PP analysis were used.
43 or 57 days after the initiation of eradication therapy
Secondary Outcomes (2)
Cost-benefit analysis
43 or 57 days after the initiation of eradication therapy
Adverse events
43 or 57 days after the initiation of eradication therapy
Study Arms (4)
Group1: Vonoprazan Fumarate + amoxicillin + doxycycline
EXPERIMENTALGroup2: Vonoprazan Fumarate + furazolidone + doxycycline
EXPERIMENTALGroup3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
EXPERIMENTALGroup4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
EXPERIMENTALInterventions
Vonoprazan Fumarate + amoxicillin + doxycycline
Vonoprazan Fumarate + furazolidone + doxycycline
esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
Eligibility Criteria
You may qualify if:
- Age ≥18 years, ≤80 years
- Urea breath test (UBT) was positive for Hp infection;
- WIthout any anti-Hp treatment before
- Endoscopy was performed within 1 month
- Understanding the purpose and procedure of the study, voluntarily participating in the study and signing a written informed consent.
You may not qualify if:
- Allergic to drugs used in this clinical study;
- Using PPI, histamine H2 receptor antagonist, antibiotics, bismuth, probiotics or drugs with antibacterial effects within 4 weeks before treatment.
- Using adrenal corticosteroids, non-steroidal anti-inflammatory drugs and anticoagulants
- The disease or clinical condition that may interfere with the treatment evaluation of the study, such as liver disease, cardiovascular disease, lung disease, kidney disease, metabolic disease, psychiatric disease, or malignant tumor
- Pregnant or lactating women
- Participated in other clinical studies within 3 months prior to the registration of this clinical study
- Suspected history of antibiotic abuse
- Patients with craniocerebral injury, mental illness or epilepsy who cannot communicate with others or other diseases that may affect follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- wang xiaoyanlead
Study Sites (1)
The third Xiangya Hospital of central south University
Changsha, Hunan, 410003, China
Related Publications (1)
Zhang Z, Liu F, Ai F, Chen X, Liu R, Zhang C, Fang N, Fu T, Wang X, Tang A. The efficacy and mechanism of vonoprazan-containing triple therapy in the eradication of Helicobacter pylori. Front Pharmacol. 2023 May 5;14:1143969. doi: 10.3389/fphar.2023.1143969. eCollection 2023.
PMID: 37214450DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Head of Gastroenterology, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
October 16, 2021
First Posted
October 28, 2021
Study Start
June 17, 2021
Primary Completion
June 17, 2022
Study Completion
October 17, 2022
Last Updated
February 18, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share