Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Location status: Recruiting
Recruiting
NCT Number: NCT06723197
Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
Vonoprazan+Amoxicillin
DrugDrug combinations for dual regimens：vonoprazan+amoxicillin
Duration of eradication regimen: 7-day
OtherDuration of eradication regimen: 7-day
vonoprazan+amoxicillin+tetracycline+bismuth
DrugDrug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth
Duration of eradication regimen: 10-day
OtherDuration of eradication regimen: 10-day
Duration of eradication regimen: 14-day
OtherDuration of eradication regimen: 14-day
Primary outcomes
-
Eradication rate
Time frame: 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 outcomes
-
Rate of adverse reactions
Time frame: Immediately after treatment
Drug-related adverse reactions needs to be recorded after treatment
-
Patient compliance
Time frame: Immediately after treatment
The number of missed and overdosed doses of medication needs to be completed after treatment.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shandong University
Other
Collaborators
- Dezhou Hospital Qilu Hospital of Shandong University
- Feicheng Municipal People's Hospital
- Shandong University of Traditional Chinese Medicine
- The People's Hospital of Jimo.Qingdao
- Zaozhuang Municipal Hospital
- Zibo Maternal and Child Health Hospital
Registry information
Official study title
Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Dec 9, 2024
- Registry last updated
- Dec 11, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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