Clinical trial NCT06977841: Tegoprazan-Based Dual Therapy With Amoxicillin vs Tetracycline for H. Pylori Eradication
Official title: Efficacy and Safety of Tegoprazan-Amoxicillin and Tegoprazan-Tetracycline Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Helicobacter Pylori Eradication
High-dose Dual Therapy
Lead sponsor: Zhongshan Hospital (Xiamen), Fudan University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: 44 days
Secondary outcomes:
measure: Frequency of the adverse events
timeFrame: 44 days
measure: Compliance rate of the drugs
timeFrame: 44 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital (Xiamen), Fudan University
state: Fujian
Study officials:
affiliation: Zhongshan Hospital (Xiamen), Fudan University
name: Yucheng Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nan XP, Zhao HY, Guo LN, Zheng RQ, Wang XL, Wang YF, Su YH, Geng WR, Liu XL, Xu HM, Zhou KL, Guo YT, Cao JH, Han ZX, Kong QZ, Zuo XL, Li YQ, Li YY. Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial. Helicobacter. 2025 Mar-Apr;30(2):e70036. doi: 10.1111/hel.70036.