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Furazolidone Quadruple Regimen Eradicate H. Pylori Infection

NCT06823791 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2025-02-12

No results posted yet for this study

Summary

Research protocol:

Experimental group:

First line solution (furazolidone regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + furazolidone 100 mg, twice daily, for 14 days.

Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days.

Control group:

First line solution (clarithromycin regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + clarithromycin 500 mg, twice a day, for 14 days.

Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days.

Main study endpoint:

The difference in the eradication rate of H. pylori infection between the furazolidone quadruple regimen and the clarithromycin quadruple regimen.

Secondary study endpoint:

1. Safety and compliance of the furazolidone quadruple regimen.
2. Comparison of high-dose dual therapy with furazolidone quadruple therapy and clarithromycin quadruple therapy on H. pylori eradication rate.
3. 1-year recurrence and recurrence rate of H. pylori infection.

Conditions

  • Helicobacter Pylori Infection
  • Eradication

Interventions

DRUG

Furazolidone

esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + furazolidone 100 mg bid, for 14 days. After stopping the medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months and 12 months, the experiment stop. If H. pylori is positive, check again after 6 months. If H. pylori is still positive, high-dose dual therapy will be used to resist H. pylori again. After stopping the second medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months, and the experiment stops. If H. pylori is still positive, check again after 6 months, and the experiment stops.

DRUG

Clarithromycin

esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + clarithromycin 500 mg bid, for 14 days. After stopping the medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months and 12 months, the experiment stop. If H. pylori is positive, check again after 6 months. If H. pylori is still positive, high-dose dual therapy will be used to resist H. pylori again. After stopping the second medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months, and the experiment stops. If H. pylori is still positive, check again after 6 months, and the experiment stops.

Sponsors & Collaborators

  • Liaocheng People's Hospital

    lead OTHER

Principal Investigators

  • Lifeng Liu · Liaocheng Peoples hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-07-30
Completion
2024-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823791 on ClinicalTrials.gov