Differences in the Eradication of Helicobacter Pylori by Different Therapies

Study Overview
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Brief Summary
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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.

Detailed Description
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A single-center, prospective, open-label, parallel control design was conducted to enroll 100 patients with confirmed Helicobacter pylori infection. Patients were randomly divided into four groups, respectively accept four treatment regimens including (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. The effectiveness, safety and compliance of the four regimens were compared, and the cost-benefit analysis of the different regimens was conducted. The purpose of this study was to explore the most appropriate treatment plan for radical treatment of Helicobacter pylori .

Official Title
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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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Group1 Vonoprazan Fumarate + amoxicillin + doxycycline
* Drug: Group2 Vonoprazan Fumarate + furazolidone + doxycycline
* Drug: Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
* Drug: Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1: Vonoprazan Fumarate + amoxicillin + doxycycline<br> | Drug: Group1 Vonoprazan Fumarate + amoxicillin + doxycycline<br>* Vonoprazan Fumarate + amoxicillin + doxycycline<br>|
| Experimental: Group2: Vonoprazan Fumarate + furazolidone + doxycycline<br> | Drug: Group2 Vonoprazan Fumarate + furazolidone + doxycycline<br>* Vonoprazan Fumarate + furazolidone + doxycycline<br>|
| Experimental: Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline<br> | Drug: Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline<br>* esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline<br>|
| Experimental: Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline<br> | Drug: Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline<br>* esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-benefit analysis | The drug cost of the two treatment options was calculated. According to the HP eradication rate, markov model was used to conduct cost-benefit analysis of the two methods, and determine which method was more cost-effective from an economic perspective. | 43 or 57 days after the initiation of eradication therapy | 
| Adverse events | Adverse drug events, significant laboratory outliers, and new diseases emerging during the study | 43 or 57 days after the initiation of eradication therapy |