Status:

UNKNOWN

14-day Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection

Lead Sponsor:

Shandong University

Conditions:

Helicobacter Pylori Infection

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomized to 14 days of dual therapy with Tegoprazan or 14 days of quadruple therapy with bismut...

Detailed Description

1. Informed consent: Patients with positive Helicobacter pylori were collected in the outpatient department, and the subjects receiving initial treatment signed informed consent. 2. Safety evaluation:...

Eligibility Criteria

Inclusion

  • Helicobacter pylori infection (either positive for Helicobacter pylori culture, histopathological test, rapid urease test, C13/C14 urea breath test, or helicobacter pylori antigen test in feces).
  • Patients who have not previously received helicobacter pylori eradication therapy.

Exclusion

  • Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
  • Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial.
  • Active gastrointestinal bleeding.
  • History of drug allergy.
  • Medication history of bismuth, antibiotics and PPI within 4 weeks.
  • Other behaviors that may increase the risk, such as alcohol and drug abuse.
  • Unable or unwilling to provide informed consent.

Key Trial Info

Start Date :

February 14 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

258 Patients enrolled

Trial Details

Trial ID

NCT05438550

Start Date

February 14 2023

End Date

December 31 2023

Last Update

February 14 2023

Active Locations (1)

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1

Qilu hosipital

Jinan, Shandong, China, 250012