Tegoprazan-Based Dual Therapy With Amoxicillin vs Tetracycline for H. Pylori Eradication

Zhongshan Hospital (Xiamen), Fudan University

Status: Not yet enrolling

Conditions: High-dose Dual Therapy; Helicobacter Pylori Eradication

Treatments: Drug: Bismuth; Drug: Tetracycline 500 Mg; Drug: Tegoprazan; Drug: Amoxicillin 250Mg Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT06977841

ZYC-Hp2025

Details and patient eligibility

About

Current first-line Helicobacter pylori eradication protocols involve multidrug regimens comprising a proton pump inhibitor (PPI) or bismuth agent combined with dual antibiotics (e.g., clarithromycin, amoxicillin, quinolones, furazolidone, nitroimidazoles, or tetracycline) administered for 7-14 days. In China, the bismuth-containing quadruple therapy (BQT) remains the standard first-line treatment for H. pylori infection. However, BQT implementation is challenged by polypharmacy burdens, substantial adverse events, and suboptimal treatment adherence. Emerging evidence suggests that simplified dual therapies pairing acid suppressants (PPIs or potassium-competitive acid blockers [P-CABs]) with high-dose amoxicillin achieve comparable eradication rates to BQT while demonstrating superior tolerability and adherence profiles. Notably, the comparative efficacy of tetracycline-based versus amoxicillin-based dual regimens remains unexamined in controlled clinical trials. Our preliminary investigations established that optimized PPI-amoxicillin dual therapy achieves >90% eradication rates in treatment-naïve populations. Building on these findings, this prospective randomized controlled trial will comparatively assess the effectiveness of tegoprazan-a novel P-CAB exhibiting potent acid inhibition-when co-administered with either amoxicillin or tetracycline in H. pylori-positive adults. The investigation aims to establish an evidence framework for streamlining eradication protocols through pharmacodynamic optimization while mitigating antimicrobial resistance development.

Enrollment: 87 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age from 18 to 65 years;
2. H.pylori infection diagnosed by 13C-urea breath test;
3. The patient infected with Helicobacter pylori has never undergone eradication therapy.

Exclusion criteria

1. Allergy to any of the medications;
2. Zollinger-Ellison syndrome, GC, Upper gastrointestinal bleeding, or Active peptic ulcer;
3. Coexistence of significant concomitant illnesses, including heart disease, renal failure, hepatic disease, previous abdominal surgery, lactation, or pregnancy;
4. Patients who had used PPI/P-CAB drugs, and antibiotics in the past 12 weeks;
5. Unwillingness to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 4 patient groups

Tegoprazan-Amoxicillin Dual Therapy

Experimental group

Treatment:

Drug: Amoxicillin 250Mg Cap

Drug: Tegoprazan

Tegoprazan-Tetracycline Dual Therapy

Experimental group

Treatment:

Drug: Tegoprazan

Drug: Tetracycline 500 Mg

Tegoprazan-Amoxicillin-Tetracycline Triple Therapy

Active Comparator group

Treatment:

Drug: Amoxicillin 250Mg Cap

Drug: Tegoprazan

Drug: Tetracycline 500 Mg

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Active Comparator group

Treatment:

Drug: Amoxicillin 250Mg Cap

Drug: Tegoprazan

Drug: Tetracycline 500 Mg

Drug: Bismuth