High-dose dual therapy and quadruple therapy for Helicobacter Pylori infection

High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection

This study is testing if a high-dose combination of two medications or a four-drug treatment can effectively clear Helicobacter pylori infections in patients.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (other)
• Locations: 10 sites (Hebi, Henan and 9 other locations)
• Trial ID: NCT06561698 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective study aims to evaluate the effectiveness of high-dose dual therapy and minocycline-containing quadruple therapy in patients diagnosed with Helicobacter pylori infection. A total of 200 patients will be enrolled, with their infection confirmed through rapid urease tests and/or 13C urea breath tests. The study will assess the success rate, adverse reactions, compliance, and antibiotic resistance related to H. pylori eradication. Patients will undergo HP culture and drug sensitivity testing after providing informed consent.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Helicobacter pylori infection who are willing to participate and provide informed consent.

Not a fit: Patients who are pregnant, have a history of gastrointestinal malignancies, or have serious organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for Helicobacter pylori infections, improving patient outcomes.

How similar studies have performed: Other studies have shown varying success with similar antibiotic therapies for Helicobacter pylori, but this specific combination is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection

Exclusion Criteria:

* Pregnant and lactating women;
* History of gastrointestinal malignancies;
* History of previous subtotal gastrectomy;
* Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
* History of hematological diseases
* People who are allergic to drugs;
* The guardian or patient refused to join the group;
* Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
* No legal capacity or poor self-knowledge
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Where this trial is running

Hebi, Henan and 9 other locations

• Hebi People's Hospital — Hebi, Henan, China (RECRUITING)
• Jiaozuo People's Hospital — Jiaozuo, Henan, China (RECRUITING)
• Luoyang central Hospital — Luoyang, Henan, China (RECRUITING)
• The first people's hospital of ping ding shan — Pingdingshan, Henan, China (RECRUITING)
• Xuchang central Hospital — Xuchang, Henan, China (RECRUITING)
• The Second Affiliated Hospital of Henan University of science and technology — Zhengzhou, Henan, China (RECRUITING)
• The Third People's Hospital of Zhengzhou — Zhengzhou, Henan, China (RECRUITING)
• Zhengzhou People's Hospital — Zhengzhou, Henan, China (RECRUITING)
• Zhoukou Central Hospital — Zhoukou, Henan, China (RECRUITING)
• Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (RECRUITING)

Conditions: Helicobacter Pylori Infection, Helicobacter pylori, minocycline, amoxicillin