Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

Last updated: August 2, 2022
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-ulcer Dyspepsia (Nud)

Treatment

N/A

Clinical Study ID

NCT05176821
JW-Hp2021
  • Ages > 18
  • All Genders

Study Summary

The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patients who were diagnosed with persistent H. pylori infection and had previouslyfailed one or more courses of eradication therapies that included amoxicillin,clarithromycin, or nitroimidazole.

Exclusion

Exclusion Criteria:

  • Age < 18 years old.
  • The time frame was less than 6 months from the previous eradication therapy.
  • The previous eradication therapy included furazolidone.
  • Allergic to the medication.
  • Pregnant or lactating women.
  • Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseasesor malignancy.
  • Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.

Study Design

Total Participants: 186
Study Start date:
January 01, 2021
Estimated Completion Date:
December 31, 2022

Study Description

Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies.

H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.

Connect with a study center

  • Zhongshan Hospital Xiamen Branch

    Xiamen, 86361015
    China

    Active - Recruiting

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