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CompletedNCT03779087Updated Oct 26, 2023

Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection

An interventional study of 10d TL quadruple therapy and 10d AL quadruple therapy in Helicobacter Pylori Infection, sponsored by Ping-I (William) Hsu, M.D.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Ping-I (William) Hsu, M.D. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2018, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study summary

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Read the detailed description

The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

02

Conditions studied

  • Helicobacter Pylori Infection

Keywords

  • Helicobacter pylori
  • Eradication rate
  • Rescue treatment
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 112 is close to the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

This is the only study on the registry with Ping-I (William) Hsu, M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)

Exclusion criteria

Exclusion Criteria:

  • previous allergic reactions to the study medications,
  • history of gastrectomy,
  • use of antibiotics within the previous 4 weeks,
  • pregnant or lactating women,
  • coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    10d TL quadruple therapy

    esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days

    Drug: 10d TL quadruple therapy

  • Active comparator
    10d AL quadruple therapy

    esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days

    Drug: 10d AL quadruple therapy

Interventions

  • Drug10d TL quadruple therapy

    esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.

    Also known as: esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, tetracycline 500 mg, levofloxacin 500 mg

  • Drug10d AL quadruple therapy

    esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.

    Also known as: esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, amoxicillin 500 mg, levofloxacin 500 mg

06

What researchers measure

Primary outcomes

  1. Number of Participants in Which H. Pylori Was Eradicated

    To assess eradication efficacy,repeated endoscopy with rapid urease test, histological

    Time frame: sixth week after the end of anti- H. pylori therapy

07

Study locations

1 site
  • Kaohsiung Veterans General Hospital
    Kaohsiung, 813, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03779087
Lead sponsor
Ping-I (William) Hsu, M.D.
Responsible party
Ping-I (William) Hsu, M.D. (Professor, Kaohsiung Veterans General Hospital.) — Sponsor-investigator
First posted
Dec 19, 2018
Start date
Jul 11, 2018
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Oct 26, 2023

Study contacts

Ping-I Hsu, Bachelor
study chair · Kaohsiung Veterans General Hospital.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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