RecruitingPhase 4NCT06723197

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

Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial

Sponsor

Shandong University

Enrollment

330 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

Helicobacter Pylori Infections

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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

Exclusion Criteria8

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%
Patients with active gastrointestinal bleeding
Patients with a history of upper gastrointestinal surgery
Patients allergic to treatment drugs
Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks
Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial
Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
Patients who are unwilling or incapable to provide informed consents