Differences in the Eradication of Helicobacter Pylori by Different Therapies

wang xiaoyan

Status: Unknown

Conditions: Helicobacter Pylori Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05097846

2021HP

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Group1: Vonoprazan Fumarate + amoxicillin + doxycycline

Experimental group

Treatment:

Drug: Group1 Vonoprazan Fumarate + amoxicillin + doxycycline

Group2: Vonoprazan Fumarate + furazolidone + doxycycline

Experimental group

Treatment:

Drug: Group2 Vonoprazan Fumarate + furazolidone + doxycycline

Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline

Experimental group

Treatment:

Drug: Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline

Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline

Experimental group

Treatment:

Drug: Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline