Clinical trial NCT05097846: Differences in the Eradication of Helicobacter Pylori by Different Therapies
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Eradication rate of Hp at one time
timeFrame: 43 or 57 days after the initiation of eradication therapy
Secondary outcomes:
measure: Cost-benefit analysis
timeFrame: 43 or 57 days after the initiation of eradication therapy
measure: Adverse events
timeFrame: 43 or 57 days after the initiation of eradication therapy
Other outcomes:
Locations:
city: Changsha
country: China
facility: The third Xiangya Hospital of central south University
state: Hunan
Study officials:
References: