Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication

Shandong University

Status and phase: Enrolling; Phase 4

Conditions: HELICOBACTER PYLORI INFECTIONS

Treatments: Other: Duration of eradication regimen: 14-day; Drug: vonoprazan+amoxicillin; Other: Duration of eradication regimen: 7-day; Other: Duration of eradication regimen: 10-day; Drug: vonoprazan+amoxicillin+tetracycline+bismuth

Study type: Interventional

Funder types: Other

Identifiers

NCT06723197

202411

Details and patient eligibility

About

The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18-70 years old
2. Patients with H.pylori infection (13C/14C-urea breath test)
3. Patients without previous treatment for H. pylori eradication

Exclusion criteria

1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%
2. Patients with active gastrointestinal bleeding
3. Patients with a history of upper gastrointestinal surgery
4. Patients allergic to treatment drugs
5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks
6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial
7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
8. Patients who are unwilling or incapable to provide informed consents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

330 participants in 3 patient groups

14-day dual regimen

Active Comparator group

Treatment:

Drug: vonoprazan+amoxicillin

Other: Duration of eradication regimen: 14-day

10-day dual regimen

Experimental group

Treatment:

Other: Duration of eradication regimen: 10-day

Drug: vonoprazan+amoxicillin

7-day quadruple regimen

Experimental group

Treatment:

Drug: vonoprazan+amoxicillin+tetracycline+bismuth

Other: Duration of eradication regimen: 7-day