Optimal Duration of Bismuth Quadruple Therapy for Helicobacter Pylori Eradication in Females as Compared With Males
NCT Number: NCT06509139
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Helicobacter Pylori Infection|Sex|Bismuth Quadruple Therapy
Interventions: DRUG: Drug: Bismuth Subcitrate 120 MG Oral Tablet|DRUG: Esomeprazole 40mg|DRUG: Metronidazole 250 MG|DRUG: Tetracycline Pill
Sponsor: National Cheng-Kung University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 661
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-09
Completion Date: 2032-07-31
Locations: Helicobacter pylori study group, National Cheng Kung University Hospital, Tainan, 70403, Taiwan

Summary:
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.

Primary Outcome Measures: The successful eradication rate, The patients stop taking the proton pump inhibitor and antibiotics for 4 to 6 weeks, and then they receive 13C-urea breath test or an H. pylori stool antigen test to confirm successful eradication or not. The successful rate is represented with a percentage (%)., About 4 to 6 weeks after receiving the H. pylori eradication regimen
Secondary Outcome Measures: Adverse effects of the bismuth-based quadruple therapy, Adverse event rates are assessed by physicians and through questionnaire surveys after treatment completion. Adverse events include dizziness, skin rash, headache, unpleasant taste, abdominal pain, nausea, vomiting, diarrhea, constipation, abdominal fullness, glossitis, darkened stool, fatigue, and anorexia. All adverse events are classified as none, mild (not restricting daily activities), or serious (restricting daily activities or causing inability to work)., Since 1st day to 4 weeks after receiving the H. pylori eradication regimen|Adherence to medications of the bismuth-based quadruple therapy, Medication adherence is assessed by physicians and through questionnaire surveys after treatment completion. Medication adherence is categorized as good (≥ 80% medication taken) or poor (\< 80% medication taken)., Since 1st day to 4 weeks after receiving the H. pylori eradication regimen