Clinical Trial to Evaluate the Efficacy of Probit-Based Triple Therapy for Helicobacter Pylori Eradication

This is a single-center, open-label, non-randomized, single-arm clinical study. Eligible participants who provide written informed consent will undergo screening based on inclusion/exclusion criteria. Enrolled subjects will receive the investigational treatment: Zastaprazan 20 mg (twice daily), clarithromycin 500 mg (twice daily), and amoxicillin 1000 mg (three times daily) for 14 days. Four to eight weeks after completing the therapy, participants will return for a urea breath test to assess H. pylori eradication. The study will also investigate the efficacy of this therapy in clarithromycin-resistant patients to indirectly assess the potential of a dual regimen using Zastaprazan and amoxicillin.

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Key information

Conditions

Helicobacter Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Helicobacter Infections Infections

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female, aged 19 to 75 years at consent.
Confirmed H. pylori positive by urease breath or enzyme test.
Require eradication therapy due to at least one condition: chronic atrophic gastritis, peptic ulcer, history of early gastric cancer or adenoma resection, functional dyspepsia, low-grade MALT lymphoma, idiopathic thrombocytopenic purpura, iron deficiency anemia, hyperplastic polyps, or family history of gastric cancer.
Agree to use medically acceptable contraception during the trial (including medically sterile women such as menopausal, hysterectomy, tubal ligation, or bilateral oophorectomy).
Provide voluntary written informed consent.

Exclusion criteria

History of receiving H. pylori eradication therapy prior to study participation.
Known hypersensitivity to the investigational product, penicillin-class antibiotics, or macrolide-class antibiotics.
Current use of medications contraindicated with the investigational product or concomitant therapy.
Abnormal laboratory values in blood chemistry tests as defined by the protocol.
pregnant or nursing women

Treatment and study plan

This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori.

Drug

This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori.

Primary outcomes

Eradication rate

Time frame: 4 to 8 weeks

Efficacy of H. pylori eradication therapy. confirmed by negative UBT test

Study contacts

Contact information is provided by the study sponsor or research team.

Byung-Hoon Min

CONTACT

[email protected]

82-2-3410-3409

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

A Single-Center, Single-Arm Clinical Trial to Evaluate the Efficacy of Probit-Based Triple Therapy for Helicobacter Pylori Eradication

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Aug 11, 2025
Registry last updated: Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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