Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection

NCT04332848 | Recruiting Phase 4

• 1 other identifier: 202001085MINB
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Therefore, we aimed to

1. 1.compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection
2. 2.assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori,Susceptibility testing,empirical,third-line treatment

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the eradication rate in the third treatment according to intention-to treat (ITT) analysis.

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

  6 weeks

Secondary Outcomes (1)

• Adverse effects

  2 weeks

Study Arms (2)

(B) Empirical therapy

EXPERIMENTAL

choose antibiotics according to drug history

Drug: ET

(A) Susceptibility testing guided therapy

ACTIVE COMPARATOR

choose antibiotics according to susceptibility testing

Drug: SGT

Interventions

ET DRUG

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

(B) Empirical therapy

SGT DRUG

Susceptibility testing guided therapy Based on susceptibility test: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple/quadruple therapy or concomitant therapy

(A) Susceptibility testing guided therapy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Study Officials

• Mei-Jyh Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Jyh Chen

CONTACT

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

Yu-Chun Huang

CONTACT

nneder34@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: July 28, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

TW (1)