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

NCT07115173 | Not Yet Recruiting Phase 4

• 1 other identifier: JAQBO_IIT_H.pylori
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Helicobacter Infection

Outcome Measures

Primary Outcomes (1)

• Eradication rate

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

  4 to 8 weeks

Study Arms (1)

This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of

EXPERIMENTAL

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.

Interventions

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.

This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Clarithromycin; Amoxicillin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Byung-Hoon Min

CONTACT

82-2-3410-3409; jason.min@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08