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Clinical Trials in China / NCT06723197
Recruiting Phase 4

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

NCT06723197 · tracked via the Priya Life Science China tracker
Sponsor
Shandong University
Phase
Phase 4
Started
2024-12-10
Last updated
2024-12-11

Condition(s) studied

HELICOBACTER PYLORI INFECTIONS

Investigational drug(s) / intervention(s)

vonoprazan+amoxicillinAll Vonoprazan trials (15) →All Amoxicillin trials (29) →Duration of eradication regimen: 7-dayvonoprazan+amoxicillin+tetracycline+bismuthAll Vonoprazan trials (15) →All Amoxicillin trials (29) →All Tetracycline trials (8) →All Bismuth trials (6) →Duration of eradication regimen: 10-dayDuration of eradication regimen: 14-day

vonoprazan+amoxicillin: Drug combinations for dual regimens：vonoprazan+amoxicillin

Duration of eradication regimen: 7-day: Duration of eradication regimen: 7-day

vonoprazan+amoxicillin+tetracycline+bismuth: Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth

Duration of eradication regimen: 10-day: Duration of eradication regimen: 10-day

Duration of eradication regimen: 14-day: Duration of eradication regimen: 14-day

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Jinan Shandong Recruiting

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Other trials for the same condition

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study Starting soon
Registry for the Management of Helicobacter Pylori Infection in Shandong Province Recruiting
The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter Pylori Starting soon
Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori） Starting soon
Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06723197 on ClinicalTrials.gov ↗ ← All trials in China