Actively Recruiting
High-dose Dual Therapy and Minocycline-containing Quadruple Therapy for Helicobacter pylori Infection
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-12-30
200
Participants Needed
10
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate and compare treatments for people infected with Helicobacter pylori, a type of bacteria that can cause stomach problems. It is a Phase 4 multicenter prospective study including 200 patients confirmed positive for H. pylori by rapid urease test or 13C urea breath test. The study will follow ethical guidelines and obtain informed consent from all participants before enrollment. Researchers will assess factors such as antibiotic resistance, success rates, adverse reactions, and patient compliance during treatment. Participants will receive either a high-dose dual therapy or a quadruple therapy containing minocycline and other medications. The drugs studied include vonoprazan (a potassium competitive acid blocker), amoxicillin, bismuth potassium citrate (which protects the stomach lining and fights H. pylori), and a combination of minocycline and metronidazole antibiotics. All patients will undergo H. pylori culture and drug sensitivity testing to guide therapy. During the study, researchers will monitor the eradication rate of H. pylori six weeks after therapy completion. They will also observe adverse reactions and patient adherence to treatment. The study includes careful follow-up and assessments to measure treatment outcomes and antibiotic resistance impact. The total participation period and further follow-up details are guided by study protocols to ensure comprehensive evaluation of therapies.
CONDITIONS
Official Title
High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed Helicobacter pylori infection
- Age between 18 and 70 years
You will not qualify if you...
- Pregnant and lactating women
- History of gastrointestinal cancers
- Previous subtotal gastrectomy
- Serious dysfunction of heart, liver, kidney, lung, or other important organs or congenital diseases such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease
- History of blood diseases
- Allergy to study drugs
- Refusal by patient or guardian to participate
- Alcohol or drug abuse or poor treatment compliance
- No legal capacity or poor self-knowledge
- Use of antibiotics, bismuth, antisecretory drugs, or Chinese herbal medicine within 8 weeks before the study
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Trial Site Locations
Total: 10 locations
1
Hebi People's Hospital
Hebi, Henan, China
Actively Recruiting
2
Jiaozuo People's Hospital
Jiaozuo, Henan, China
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3
Luoyang central Hospital
Luoyang, Henan, China
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4
The first people's hospital of ping ding shan
Pingdingshan, Henan, China
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5
Xuchang central Hospital
Xuchang, Henan, China
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6
The Second Affiliated Hospital of Henan University of science and technology
Zhengzhou, Henan, China
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7
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
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8
Zhengzhou People's Hospital
Zhengzhou, Henan, China
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9
Zhoukou Central Hospital
Zhoukou, Henan, China
Actively Recruiting
10
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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