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

Phase 4

Recruiting

• Conditions: HELICOBACTER PYLORI INFECTIONS
• Interventions: Drug: vonoprazan+amoxicillin; Drug: vonoprazan+amoxicillin+tetracycline+bismuth

• Registration Number: NCT06723197
• Lead Sponsor: Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Study Start: 2024-12-10
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14-day dual regimen	vonoprazan+amoxicillin	-
10-day dual regimen	vonoprazan+amoxicillin	-
7-day quadruple regimen	vonoprazan+amoxicillin+tetracycline+bismuth	-

Primary Outcome Measures

Name	Time	Method
Eradication rate	Six weeks after treatment	13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

Secondary Outcome Measures

Name	Time	Method
Rate of adverse reactions	Immediately after treatment	Drug-related adverse reactions needs to be recorded after treatment
Patient compliance	Immediately after treatment	The number of missed and overdosed doses of medication needs to be completed after treatment.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China