Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori

Not Applicable

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days; Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days; Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days

• Registration Number: NCT06299605
• Lead Sponsor: Shandong University

Brief Summary

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy 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

H. pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention:

14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.

Study Timeline

• Study First Submitted: 2024-02-19
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-08
• Study Start: 2024-11-27
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

1. Patients aged 18-70 years old;
2. Patients with H.pylori infection (positive rapid urease test, 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 quadruple regimen	Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
14-day triple regimen	Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
7-day triple regimen	Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

Primary Outcome Measures

Name	Time	Method
Eradication rate	Immediately after follow-up check	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 follow-up check	A questionnaire on drug-related adverse reactions needs to be completed after treatment.
Patient compliance	Immediately after follow-up check	A questionnaire on the number of missed and overdosed doses of medication needs to be completed after treatment. Good compliance was defined as taking 80%-120% of the pills.

Trial Locations

Locations (1)

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