2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment.
Liya Zhou, Hong Lu, Zhiqiang Song...
https://pubmed.ncbi.nlm.nih.gov/36579940/Actively Recruiting
Led by Shandong University · Updated on 2024-12-11
330
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication
Y
Yanqing Li, Ph.D
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Shandong University
Lead Sponsor
Zibo Maternal and Child Health Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Duration - 6 weeks
Participants are evaluated for eradication success and adverse reactions six weeks after treatment completion.
1 follow-up visit
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Lead Sponsor
Zibo Maternal and Child Health Hospital
Collaborating Sponsor