New treatment approach for Helicobacter pylori infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a modified sequential therapy for Helicobacter pylori infection, which combines vonoprazan with high-dose amoxicillin in two phases. The first phase involves a standard dosage of amoxicillin, while the second phase increases the dosage to enhance efficacy and reduce side effects. The study aims to compare this new regimen with standard dual therapy over a 14-day period, focusing on eradication rates, efficacy, and patient tolerance. By gradually increasing the drug dosage, the trial seeks to improve patient adherence and minimize adverse effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-70 years, gender unrestricted.
2. Chronic gastritis patients with Helicobacter pylori positivity: (1) Helicobacter pylori positive is defined as a positive result on a carbon-13 or carbon-14 breath test within one month prior to enrollment; (2) Chronic gastritis is defined as a diagnosis based on gastroscopy within six months prior to enrollment.
3. No previous Helicobacter pylori eradication therapy.
4. Agree to participate in the trial and sign the informed consent form

Exclusion Criteria:

1. Allergy to any of the drugs used in this clinical trial.
2. Previously received H. pylori eradication treatment.
3. Receiving Potassium-competitive acid blocker (P-CAB), proton pump inhibitor (PPI), H2 receptor antagonist, antibiotics, bismuth, probiotic preparations 4 weeks before initiating study treatment.
4. Use of non-steroidal anti-inflammatory drugs (NSAIDs), adrenal corticosteroids, or anticoagulants during the study period.
5. Pregnant or lactating women, or patients planning to conceive during the study period.
6. Patients with hepatic or renal dysfunction, or those with severe concomitant diseases that may affect the evaluation of this study, such as heart disease, lung disease, liver disease, kidney disease, metabolic disorders, mental illnesses, malignant tumors, etc..
7. Gastroscopy findings indicating conditions other than gastritis, such as reflux esophagitis, which require continued use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H2 receptor antagonists, or bismuth after Helicobacter pylori eradication.
8. Patients with a history of gastric surgery.
9. Patients who are unable to accurately express their symptoms, such as those with psychiatric disorders or severe neurosis, and are unable to cooperate with the trial.
10. Patients who have participated in other drug studies within 3 months before using the investigational drug.
11. Other conditions deemed by the investigator as unsuitable for participation in this trial.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Feng Ye, PhD
• Email: fengye@njmu.edu.cn
• Phone: 86+13815897873

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fecal transplant to help eradicate stubborn Helicobacter pylori infection

  This study tests whether giving a fecal microbiota transplant can help people with Helicobacter pylori infection that has not responded to standard treatments.

  Recruiting Phase 4 Sichuan Provincial People's Hospital · Chengdu, Sichuan · NCT07704255

• Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori

  We are testing whether a two-drug regimen of vonoprazan plus clarithromycin clears H. pylori in adults whose fecal PCR shows no clarithromycin resistance mutations.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07439445

• Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection

  This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.

  Recruiting Kaohsiung Medical University · Kaohsiung City · NCT07358130

• P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection

  This study tests whether using potassium-competitive acid blockers (P-CABs) in bismuth-containing quadruple therapy works better and is safe for adults with H. pylori infection.

  Recruiting Qilu Hospital of Shandong University · Jinan · NCT07285096

• Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children

  This project will try adding bismuth to standard antibiotic and PPI treatment to see if it helps clear H. pylori and heal ulcers in children.

  Recruiting Can Tho University of Medicine and Pharmacy · Can Tho · NCT07260006

• Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication

  This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.

  Recruiting Phase 2/3 First People's Hospital of Hangzhou · Hangzhou, Zhejiang · NCT07242456

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.