Differences in the Eradication of Helicobacter Pylori by Different Therapies

wang xiaoyan100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Helicobacter Pylori Infection

Interventions

Group1 Vonoprazan Fumarate + amoxicillin + doxycyclineDRUG

Vonoprazan Fumarate + amoxicillin + doxycycline

Group2 Vonoprazan Fumarate + furazolidone + doxycyclineDRUG

Vonoprazan Fumarate + furazolidone + doxycycline

Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycyclineDRUG

esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The third Xiangya Hospital of central south University

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 43 or 57 days after the initiation of eradication therapy

Secondary Outcomes

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.

Time frame: 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

Time frame: 43 or 57 days after the initiation of eradication therapy

Central Contacts

Xiaoyan Wang, MD,PhD

CONTACT

+8613974889301 wangxiaoyan@csu.edu.cn

Zinan Zhang, MD

CONTACT

+8615273169959 classroom0705@163.com

Data from ClinicalTrials.gov

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