Differences in the Eradication of Helicobacter Pylori by Different Therapies

Not Applicable

• Conditions: Helicobacter Pylori Infection
• Interventions: 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

• Registration Number: NCT05097846
• Lead Sponsor: wang xiaoyan

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.

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 Timeline

• Study Start: 2021-06-17
• Study First Submitted: 2021-10-16
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-18
• Primary Completion: 2022-06-17
• Study Completion: 2022-10-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1: Vonoprazan Fumarate + amoxicillin + doxycycline	Group1 Vonoprazan Fumarate + amoxicillin + doxycycline	-
Group2: Vonoprazan Fumarate + furazolidone + doxycycline	Group2 Vonoprazan Fumarate + furazolidone + doxycycline	-
Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline	Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline	-
Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline	Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline	-

Primary Outcome Measures

Name	Time	Method
Eradication rate of Hp at one time	43 or 57 days after the initiation of eradication therapy	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.

Secondary Outcome Measures

Name	Time	Method
Cost-benefit analysis	43 or 57 days after the initiation of eradication therapy	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.
Adverse events	43 or 57 days after the initiation of eradication therapy	Adverse drug events, significant laboratory outliers, and new diseases emerging during the study

Trial Locations

Locations (1)

The third Xiangya Hospital of central south University; 🇨🇳 Changsha, Hunan, China