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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: 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

Detailed Description

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoyan Wang, MD,PhD; Phone Number: +8613974889301; Email: wangxiaoyan@csu.edu.cn
• Study Contact Backup: Name: Zinan Zhang, MD; Phone Number: +8615273169959; Email: classroom0705@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410003
      • Recruiting
      • The Third Xiangya Hospital of Central South University
      • Contact: Zinan Zhang, MD; Phone Number: +8615273169959; Email: classroom0705@163.com
      • Contact: Xiaoyan Wang, MD; Phone Number: +8613974889301; Email: wangxiaoyan@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years, ≤80 years
2. Urea breath test (UBT) was positive for Hp infection;
3. WIthout any anti-Hp treatment before
4. Endoscopy was performed within 1 month
5. Understanding the purpose and procedure of the study, voluntarily participating in the study and signing a written informed consent.

Exclusion Criteria:

1. Allergic to drugs used in this clinical study;
2. Using PPI, histamine H2 receptor antagonist, antibiotics, bismuth, probiotics or drugs with antibacterial effects within 4 weeks before treatment.
3. Using adrenal corticosteroids, non-steroidal anti-inflammatory drugs and anticoagulants
4. 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
5. Pregnant or lactating women
6. Participated in other clinical studies within 3 months prior to the registration of this clinical study
7. Suspected history of antibiotic abuse
8. Patients with craniocerebral injury, mental illness or epilepsy who cannot communicate with others or other diseases that may affect follow-up

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group1: Vonoprazan Fumarate + amoxicillin + doxycycline	Drug: Group1 Vonoprazan Fumarate + amoxicillin + doxycycline; Vonoprazan Fumarate + amoxicillin + doxycycline
Experimental: Group2: Vonoprazan Fumarate + furazolidone + doxycycline	Drug: Group2 Vonoprazan Fumarate + furazolidone + doxycycline; Vonoprazan Fumarate + furazolidone + doxycycline
Experimental: Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline	Drug: Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline; esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
Experimental: Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline	Drug: Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline; esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: wang xiaoyan

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Anticipated): June 17, 2022
• Study Completion (Anticipated): October 17, 2022

Study Registration Dates

• First Submitted: October 16, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Monoamine Oxidase Inhibitors; Antimalarials; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Doxycycline; Amoxicillin; Esomeprazole; Bismuth; Furazolidone
• Other Study ID Numbers: 2021HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No