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Optimal Duration of Bismuth Quadruple Therapy for Helicobacter Pylori Eradication in Females As Compared with Males

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study Identification, Study Status, Oversightv3
  2. Minor Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Helicobacter pylori eradication can reduce the risk of gastric cancer and decrease the recurrence of ulcers. However, in recent years, the increasing antibiotic resistance of Helicobacter pylori has reduced the efficacy of clarithromycin-based triple therapy to below 80%. The recent studies, including real-world data and a clinical trial, have consistently found that females have poorer eradication rate of Helicobacter pylori as compared with males. In previous clinical trial, investigators discovered that the efficacy of a 10-day bismuth quadruple therapy was not inferior to a 14-day bismuth quadruple therapy. However, it remains to be investigated whether the 10-day bismuth quadruple therapy is still non-inferior to the 14-day regimen in females. This project continues the clinical trial to investigate whether the efficacy of the 10-day bismuth quadruple therapy in females is inferior to that in males and whether the 14-day bismuth quadruple therapy is superior to the 10-day regimen in females. The ultimate goal is to establish that male patients can use the 10-day bismuth quadruple therapy with fewer side effects and without compromising efficacy as compared with the 14-day regimen; while female patients are recommended to use the 14-day bismuth quadruple therapy as it would be more effective than the 10-day regimen. Considering sex in research is becoming increasingly important, as females have more antibiotic-resistant Helicobacter pylori infection than males. The bismuth quadruple therapy can overcome most resistance issues. Researching and comparing the difference in the efficacy of bismuth quadruple therapy for Helicobacter pylori eradication between females and males are of significant clinical importance and align with current research trends.
Trial Details
NCT Number NCT06509139
Lead Sponsor National Cheng-Kung University Hospital
Conditions
(from sponsor)
Helicobacter Pylori Infection, Sex, Bismuth Quadruple Therapy
Related terms Coitus
Enrollment 661 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov