Helicobacter Pylori Infection
Conditions
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 .
Interventions
DRUGGroup1 Vonoprazan Fumarate + amoxicillin + doxycycline
Vonoprazan Fumarate + amoxicillin + doxycycline
DRUGGroup2 Vonoprazan Fumarate + furazolidone + doxycycline
Vonoprazan Fumarate + furazolidone + doxycycline
DRUGGroup3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
DRUGGroup4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
Sponsors
wang xiaoyan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXiaoyan Wang, MD,PhD
Backup ContactZinan Zhang, MD
Outcome results
None listed