Efficacy of Vonoprazan-based Rescue Therapy for H. Pylori Eradication

NCT07130253 | Not Yet Recruiting

• 1 other identifier: 202506082MINA
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.This study aims to compare the efficacy of empirical vonoprazan-based therapy versus susceptibility-guided vonoprazan-based therapy for third-line eradication of H. pylori.
2. 2.We also plan to explore the impact of eradication therapy on gut microbiota, fecal antibiotic resistance, and metabolic parameters before and after treatment.

Conditions

HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (1)

• Eradication rate by intention-to-treat analysis

  Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment.

  6-8 weeks

Secondary Outcomes (1)

• Eradication rate by per-protocol analysis and Frequency of adverse effects.

  6-8 weeks

Study Arms (2)

Empirical vonoprazan-based therapy

EXPERIMENTAL

Drug: Vonoprazan based ET

Susceptibility-guided vonoprazan-based therapy

ACTIVE COMPARATOR

Drug: Vonoprazan based SGT

Interventions

Vonoprazan based ET DRUG

Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or quadruple therapy

Empirical vonoprazan-based therapy

Vonoprazan based SGT DRUG

Susceptibility testing guided therapy Based onsusceptibility test:Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin quadruple therapy

Susceptibility-guided vonoprazan-based therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Helicobacter pylori infected individuals who have failed at least two previous eradication therapies.
• Willing to undergo third-line eradication therapy.
• Subjects must be 20 years of age or older.

You may not qualify if:

• History of gastrectomy.
• Individuals unsuitable for the study medication, such as those with a history of allergy or severe adverse reactions to the study drugs, quinolone or fluoroquinolone antibiotics, or women who are pregnant or breastfeeding.
• Presence of severe acute or chronic diseases such as renal failure, liver cirrhosis, incurable malignant tumors, or a history of aortic aneurysm or dissection.
• Patients with chronic hepatitis (AST or ALT \> 100 U/L).
• Unwillingness to comply with the treatment plan or sign the informed consent form.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

• Jyh-Ming Liou, MD, PhD

  National Taiwan University Hospital

  STUDY DIRECTOR

• Mei-Jyh Chen, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Jyh Chen, MD, PhD

CONTACT

886-2-23123456 Ext. 265427; migichen@ntuh.gov.tw

Yu-Chun Huang

CONTACT

nneder34@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)