Helicobacter Pylori InfectionPhase 4NCT04332848
Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection
A Phase 4 study testing ET and SGT in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Aim: Therefore, we aimed to 1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection 2. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- ET and SGT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jul 2020to Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yu-Chun Huang contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Mei-Jyh Chen, MD
About this study
Official title: Comparison of Susceptibility Testing Guided Versus Empirical Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial
Aim: Therefore, we aimed to
- compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection
- assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors.
Read more
Methods: This will be a multi-center, open labeled trial
Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori:
Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics.
Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy
Outcome Measurement:
Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses.
Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- ET, SGT
- Keywords
- Helicobacter pylori,Susceptibility testing,empirical,third-line treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETDrug
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
SGTDrug
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
| Study group | Role | What they receive |
|---|---|---|
| (B) Empirical therapy | Experimental | choose antibiotics according to drug history Receives: Drug: ET |
| (A) Susceptibility testing guided therapy | Active comparator | choose antibiotics according to susceptibility testing Receives: Drug: SGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Adverse effects
A standard interview and questionaire will be used to assess the adverse effects.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start28 Jul 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei-Jyh Chen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332848
- Sponsor's protocol ID
- 202001085MINB
- Status last verified
- Aug 2025
- First submitted
- 1 Apr 2020
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No