Ten-Day Vonoprazan-Amoxicillin Dual Therapy as a First-Line Treatment of Helicobacter pylori Infection Compared With Bismuth-Containing Quadruple Therapy.
Hai-Sheng Qian, Wen-Jie Li, Yi-Ni Dang...
https://pubmed.ncbi.nlm.nih.gov/36729890Actively Recruiting
Phase 4
Age: 18Years - 70Years
All Genders
ID06723197
Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial
Led by Shandong University · Updated on 2024-12-11
330
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
S
Shandong University
Lead Sponsor
Z
Zibo Maternal and Child Health Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different treatment plans to eradicate Helicobacter pylori infection, comparing dual and quadruple drug regimens with varying durations of 7, 10, and 14 days. The study aims to determine which combination and duration are most effective and safe for patients. This is a Phase 4 randomized controlled trial led by Shandong University. Participants will be randomly assigned to receive one of three treatments: a 14-day dual regimen of vonoprazan and amoxicillin, a 10-day dual regimen of the same drugs, or a 7-day quadruple regimen that adds tetracycline and bismuth to vonoprazan and amoxicillin. Each regimen is studied for its ability to clear the infection over these different time frames. During the study, participants will be monitored and tested with a 13C-urea breath test six weeks after treatment to assess eradication success. Researchers will also track any adverse reactions and measure how well patients follow their treatment plans immediately after finishing therapy. The study will last until November 2025 and includes careful monitoring to evaluate both effectiveness and safety outcomes.
CONDITIONS
Brief Title
Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18-70 years old
- Confirmed Helicobacter pylori infection by 13C or 14C urea breath test
- No previous treatment for Helicobacter pylori eradication
You will not qualify if you...
- Serious underlying diseases such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumors, coronary heart disease or artery stenosis greater than 75%
- Active gastrointestinal bleeding
- History of upper gastrointestinal surgery
- Allergy to treatment drugs
- Recent use of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks
- Pregnant or lactating women, or those unwilling to use contraception during the trial
- Behaviors increasing illness risk such as alcohol or drug abuse
- Unwilling or unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 7 to 14 days
Participants receive one of the drug regimens combining vonoprazan, amoxicillin, tetracycline, and bismuth for Helicobacter pylori eradication for 7, 10, or 14 days depending on their assigned group.
1 baseline visit and 1 visit immediately after treatment
Follow-up
Duration - 6 weeks
Participants are evaluated for eradication success and adverse reactions six weeks after treatment completion.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
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Research Team
Y
Yanqing Li, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Vonoprazan and amoxicillin dual therapy as the first-line treatment of Helicobacter pylori infection: A systematic review and meta-analysis.
Ren-Chun Du, Yu-Xin Hu, Yaobin Ouyang...
https://pubmed.ncbi.nlm.nih.gov/380369412022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment.
Liya Zhou, Hong Lu, Zhiqiang Song...
https://pubmed.ncbi.nlm.nih.gov/36579940Helicobacter pylori Infection.
Sheila E Crowe
https://pubmed.ncbi.nlm.nih.gov/30893536Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis.
Yunhao Li, Horace Choi, Kathy Leung...
https://pubmed.ncbi.nlm.nih.gov/37086739