Efficacy and Safety of Second-Line Helicobacter Pylori Eradication

NCT07855497 | Active Not Recruiting

• 2 other identifiers: B-2011-649-0042025-ER1104-01
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects with persistent H. pylori infection after first-line treatment failure receives either a 14-day PPI-based moxifloxacin triple regimen (esomeprazole, amoxicillin, and moxifloxacin) or a 14-day P-CAB-bismuth-containing moxifloxacin quadruple regimen (tegoprazan, amoxicillin, moxifloxacin, and bismuth).

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

HELICOBACTER PYLORI; Moxifloxacin; Bismuth; Sex differences

Outcome Measures

Primary Outcomes (1)

• The efficacy of H. pylori eradication

  Success rate of H. pylori eradication of each regimen (ITT and PP)

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Adverse events

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

P-CAB-BM quad

EXPERIMENTAL

14-day PPI-based moxifloxacin triple regimen (esomeprazole, amoxicillin, and moxifloxacin)

Drug: P-CAB-BM quadruple regimen

Moxifloxacin triple

ACTIVE COMPARATOR

14-day P-CAB-bismuth-containing moxifloxacin quadruple regimen (tegoprazan, amoxicillin, moxifloxacin, and bismuth)

Drug: Moxifloxacin triple regimen

Interventions

P-CAB-BM quadruple regimen DRUG

Esomeprazole, amoxicillin, and moxifloxacin

Also known as: Esomeprazole, amoxicillin, and moxifloxacin regimen

P-CAB-BM quad

Moxifloxacin triple regimen DRUG

Tegoprazan, amoxicillin, moxifloxacin, and bismuth

Also known as: Tegoprazan, amoxicillin, moxifloxacin, and bismuth regimen

Moxifloxacin triple

Eligibility Criteria

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

You may qualify if:

• Adult patients with persistent H. pylori infection after failure of first-line eradication therapy
• H. pylori infection was confirmed by at least one positive result on the 13C-urea breath test (UBT), rapid urease test, or histology
• Patients who provided written informed consent and who are able to complete symptom questionnaires

You may not qualify if:

• Individuals younger than 19 years, pregnant or lactating females, patients with previous total gastrectomy, severe systemic diseases, recent use of antibiotics or acid-suppressive medications, drug allergies, or other conditions considered inappropriate by the investigators

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; tegoprazan; Moxifloxacin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Nayoung Kim, M.D., Ph.D.

  Seoul National University Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants with confirmed failure of first-line H. pylori eradication therapy are randomly assigned to receive either P-CAB and BM-containing moxifloxacin quadruple therapy (tegoprazan 50 mg twice daily, amoxicillin 500 mg four times daily, moxifloxacin 400 mg once daily, and tripotassium dicitrate BM 300 mg four times daily; P-CAB-BM quad regimen) or conventional PPI-based moxifloxacin triple ther- apy (esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, and moxifloxacin 400 mg once daily; moxifloxacin triple regimen) for 14 days.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: February 1, 2021
• Primary Completion: September 28, 2026
• Study Completion (Estimated): September 28, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)