Efficacies of Tetracycline-levofloxacin, Standard Bismuth, Amoxicillin-levofloxacin Quadruple Therapy for H.p

Efficacies of Tetracycline-levofloxacin Quadruple Therapy, Standard Bismuth Quadruple Therapy and Amoxicillin-levofloxacin Quadruple Therapy in the Second-line Treatment of H Pylori Infection

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05850117

Enrollment

240

Registered

2023-05-09

Start date

2020-02-10

Completion date

2024-12-31

Last updated

2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Eradication

Brief summary

1. Compare the efficacy of Tetracycline combined with levofloxacin quadruple therapy, standard tincture quadruple therapy and amoxicillin combined with levofloxacin quadruple therapy on the second line of Helicobacter pylori sterilization. 2. To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.

Detailed description

The standard tincture quadruple therapy and the proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a Tetracycline combined with levofloxacin quadruple therapy for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (\> 95%). A randomized controlled trial confirmed that the elimination rate of Tetracycline combined with levofloxacin quadruple therapy was better than proton pump inhibitor combined with fluoroquinolone after standard triple therapy and non-tank tetratherapy sterilization failure. Triple therapy with amoxicillin.

Interventions

DRUGesomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin

Tetracycline combined with levofloxacin quadruple therapy

DRUGesomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole

standard tincture quadruple therapy

DRUGesomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin

amoxicillin combined with levofloxacin quadruple therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

1.Tetracycline combined with levofloxacin quadruple therapy 2. standard tincture quadruple therapy 2. amoxicillin combined with levofloxacin quadruple therapy

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. at least 20 years old 2. subject was failure for the first line therapy of Helicobacter pylori

Exclusion criteria

1. Those who are allergic to the drugs used in this study 2. Those who have had a stomach surgery 3. Those who have antibiotics within four weeks of treatment 4. Those who have severe cirrhosis, uremia or malignancy 5. Those who are a pregnant woman or a woman who breastfeeds

Design outcomes

Primary

Measure	Time frame	Description
the rate of Helicobacter pylori	6 week after finish study drugs	evalute eradication outcome by 13C urea breath test

Secondary

Measure	Time frame	Description
genotype analysis	2 weeks after finishing study drgus	CYP2C19 genotype, IL-1B-511 genotype

Countries

Taiwan

Contacts

Primary ContactDeng-Chyang Wu, MD, PhD

dechwu@yahoo.com88673121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026