Differences in the Eradication of Helicobacter Pylori by Different Therapies

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097846
• Other study ID #: 2021HP
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: October 17, 2022

Study information

• Verified date: February 2022
• Source: The Third Xiangya Hospital of Central South University
• Contact: Xiaoyan Wang, MD,PhD
• Phone: +8613974889301
• Email: wangxiaoyan[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Group1 Vonoprazan Fumarate + amoxicillin + doxycycline
Vonoprazan Fumarate + amoxicillin + doxycycline
• Group2 Vonoprazan Fumarate + furazolidone + doxycycline
Vonoprazan Fumarate + furazolidone + doxycycline
• Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
• Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline

Locations

Country	Name	City	State
China	The third Xiangya Hospital of central south University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
wang xiaoyan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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