Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial

Summary

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.

Conditions

• Helicobacter Pylori Eradication
• Adverse Reaction

Interventions

DRUG

Tegoprazan

50 mg twice daily (BID), d1-14.

DRUG

Amoxicillin

In the Tegoprazan-Amoxicillin Dual Therapy group, amoxicillin 750 mg four times daily (QID) on days 1-14; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy group and the Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy group, amoxicillin 1000 mg twice daily.

DRUG

Tetracycline

In the Tegoprazan-Tetracycline Dual Therapy group, tetracycline tablets 500 mg (Hainan Pharmaceutical Factory Co., Ltd. No. 1 Pharmaceutical Factory) were administered four times daily; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy and Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy groups, tetracycline tablets 500 mg were administered three times daily.

DRUG

Bismuth

In the Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy group, bismuth potassium citrate capsules 240 mg (Hunan Warner Pharmaceutical Co., Ltd.) were administered twice daily.

Sponsors & Collaborators

• Zhongshan Hospital (Xiamen), Fudan University

  lead OTHER

Principal Investigators

• Yucheng Zhu, Ph.D. · Zhongshan Hospital (Xiamen), Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-10

Primary Completion

2026-03-10

Completion

2026-03-10

Countries

• China

Study Locations