Status:

NOT_YET_RECRUITING

The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection

Lead Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Conditions:

Helicobacter Pylori Infection

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

PHASE3

Brief Summary

The goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to an...

Eligibility Criteria

Inclusion

  • Aged 18-65 years, no history of eradication therapy;
  • Diagnosed with Helicobacter pylori infection by one or more of the following methods: gastric mucosal histochemical staining, tissue culture, 14C-UBT, 13C-UBT and/or fecal antigen;
  • Patients with warning symptoms, family history of gastric cancer or over 40 years old should undergo endoscopic examination before eradication therapy;
  • Voluntarily participate in clinical trials and sign informed consent.

Exclusion

  • Use of antibiotics or bismuth within 4 weeks before enrollment, or use of acid suppressants (including H2RA, PPI or P-CAB) within 2 weeks;
  • Active peptic ulcer with complications such as bleeding, perforation or obstruction;
  • History of esophagectomy or gastrectomy;
  • Allergy to any study drug;
  • Pregnancy or lactation;
  • History of alcoholism or drug abuse;
  • Mental illness;
  • Incapacity for civil conduct.

Key Trial Info

Start Date :

September 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2025

Estimated Enrollment :

855 Patients enrolled

Trial Details

Trial ID

NCT06591494

Start Date

September 15 2024

End Date

December 30 2025

Last Update

September 19 2024

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The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection | DecenTrialz