Rescue Therapy for Helicobacter Pylori Infection

Last updated: December 26, 2024
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Tetracycline

Metronidazole

Bismuth Potassium Citrate

Clinical Study ID

NCT05874544
rjhy20230001
  • Ages 18-70
  • All Genders

Study Summary

Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability and willingness to participate in the study and to sign and give informedconsent

  • Confirmed H. pylori infection and with previous treatment experience

Exclusion

Exclusion Criteria:

  • subjects naive to H. pylori treatment,

  • under 18 or over 80 years old

  • history of gastrectomy

  • pregnant or lactating women

  • Previous history of tuberculosis

  • Allergy to any of the study drugs

  • severe systemic diseases or malignancy

  • administration of antibiotics, bismuth, antisecretory drugs, or Chinese herbmedicine in the preceding 8 weeks

Study Design

Total Participants: 360
Treatment Group(s): 6
Primary Treatment: Tetracycline
Phase: 4
Study Start date:
May 16, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

  • Shanghai Songjiang District Central Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University school of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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