Optimizing H. Pylori Eradication Regimen Under Intensified Acid Suppression

NCT07750938 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: V2.0/2026-05-15
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Helicobacter pylori (H. pylori) infection affects approximately 50% of the global population and is closely associated with chronic gastritis, peptic ulcer disease, and gastric cancer. Eradication of H. pylori can reduce the overall risk of gastric cancer by 39%. Current international guidelines recommend bismuth-containing quadruple therapy as first-line treatment; however, its complex regimen, adverse effects, cost, and suboptimal patient adherence limit its clinical application. Potent acid suppression is essential for H. pylori eradication, as maintaining an intragastric pH of 6-8 enhances the stability of acid-labile antibiotics and promotes bacterial replication, thereby increasing antibiotic susceptibility. Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, potent, and sustained acid suppression with dose-dependent effects. Keverprazan hydrochloride is a novel P-CAB with demonstrated dose-dependent acid suppression and favorable safety profiles in Phase I and Phase III studies. Whether an intensified P-CAB dosing strategy can allow treatment shortening and regimen simplification while maintaining high eradication rates warrants investigation. Objective: To evaluate the efficacy and safety of a 10-day high-dose keverprazan dual therapy versus a standard 14-day keverprazan-based bismuth quadruple therapy for first-line H. pylori eradication. Study Design: This is a multicenter, open-label, randomized controlled trial. Eligible participants (aged 18-70 years with confirmed H. pylori infection and no prior eradication history) will be randomly assigned in a 1:1 ratio to one of two treatment arms: Arm A (Dual therapy, 10 days): Keverprazan 20 mg three times daily plus minocycline 100 mg twice daily. Arm B (Quadruple therapy, 14 days): Keverprazan 20 mg twice daily, bismuth potassium citrate 240 mg twice daily, amoxicillin 1000 mg twice daily, and minocycline 100 mg twice daily. The primary efficacy assessment will be performed at 6 weeks post-treatment using the 13C-urea breath test. A total of 316 participants (158 per arm) will be enrolled, accounting for an estimated 10% dropout rate. Outcome Measures: Primary Outcome: H. pylori eradication rate at 6 weeks after completion of treatment. Secondary Outcomes: Safety and tolerability (adverse events, laboratory abnormalities) and treatment adherence.

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

minocycline; helicobacter pylori; 10 day; dual therapy; keverprazan

Outcome Measures

Primary Outcomes (1)

• H. pylori Eradication Rate

  The proportion of participants achieving successful H. pylori eradication, defined as a negative 13C-urea breath test result, assessed at 6 weeks after completion of treatment.

  6 weeks post-treatment

Secondary Outcomes (2)

• Incidence of Adverse Events

  From first dose to 6 weeks post-treatment

• Treatment Adherence Rate

  At the end of treatment (Day 10+3 for Arm A; Day 14+3 for Arm B)

Study Arms (2)

High-Dose Keverprazan Dual Therapy for 10 Days

EXPERIMENTAL

Keverprazan 20 mg tid Minocycline 100 mg bid (All medications administered orally for 10 consecutive days)

Drug: Keverprazan Hydrochloride 20 mg TID; Drug: Minocycline 100 mg (10-Day Regimen)

Keverprazan-Based Quadruple Therapy for 14 Days

EXPERIMENTAL

Keverprazan 20 mg bid Bismuth Potassium Citrate 240 mg bid Amoxicillin 1000 mg bid Minocycline 100 mg bid (All medications administered orally for 14 consecutive days.)

Drug: Keverprazan Hydrochloride 20 mg BID; Drug: Bismuth Potassium Citrate 240 mg; Drug: Amoxicillin 1000 mg; Drug: Minocycline 100 mg (14-Day Regimen)

Interventions

Keverprazan Hydrochloride 20 mg TID DRUG

Participants will receive keverprazan hydrochloride 20 mg orally three times daily for 10 days.

High-Dose Keverprazan Dual Therapy for 10 Days

Minocycline 100 mg (10-Day Regimen) DRUG

Participants will receive minocycline 100 mg orally twice daily for 10 days.

High-Dose Keverprazan Dual Therapy for 10 Days

Keverprazan Hydrochloride 20 mg BID DRUG

Participants will receive keverprazan hydrochloride 20 mg orally twice daily for 14 days.

Keverprazan-Based Quadruple Therapy for 14 Days

Bismuth Potassium Citrate 240 mg DRUG

Participants will receive bismuth potassium citrate 240 mg orally twice daily for 14 days.

Keverprazan-Based Quadruple Therapy for 14 Days

Amoxicillin 1000 mg DRUG

Participants will receive amoxicillin 1000 mg orally twice daily for 14 days.

Keverprazan-Based Quadruple Therapy for 14 Days

Minocycline 100 mg (14-Day Regimen) DRUG

Participants will receive minocycline 100 mg orally twice daily for 14 days.

Keverprazan-Based Quadruple Therapy for 14 Days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 70 years, male or female.
• Confirmed H. pylori infection, defined as a positive 13C-urea breath test (13C-UBT) plus at least one positive result from the following: stool H. pylori antigen test, rapid urease test, or gastric mucosal histopathology.
• No prior history of H. pylori eradication therapy.

You may not qualify if:

• Known allergy or hypersensitivity to any of the study drugs (keverprazan, amoxicillin, minocycline, bismuth).
• Acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury, or acute duodenal mucosal injury at screening.
• Severe underlying diseases, including: hepatic or renal insufficiency; immunosuppression; malignancy; severe central nervous system, cardiovascular, or respiratory diseases.
• Use of antibiotics, bismuth-containing preparations, or Chinese herbal medicines with antimicrobial effects within 4 weeks prior to the screening 13C-UBT; use of proton pump inhibitors (PPIs) or potassium-competitive acid blockers (P-CABs) within 2 weeks prior to the screening 13C-UBT.
• Risk behaviors such as drug abuse or alcohol dependence.
• Pregnancy, breastfeeding, or unwillingness to use contraception during the study period.
• Current use of atazanavir sulfate or rilpivirine hydrochloride at screening.
• Requirement during the 14-day treatment period for any of the following medications: ergotamine, dihydroergotamine, probenecid, allopurinol, or methotrexate.
• Inability or unwillingness to provide informed consent.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

cyclopia sequence

Interventions

Minocycline; Clinical Protocols; BID protein, human; Amoxicillin

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 10, 2028
• Study Completion (Estimated): August 10, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share