Treatment options for Helicobacter pylori infection
Helicobacter Pylori Eradication and Follow-up in Zhongshan Hospital
This study is testing different combinations of medications to find the best way to treat Helicobacter pylori infection while using fewer antibiotics for adults aged 18 to 75.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 4447 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05061732 on ClinicalTrials.gov |
What this trial studies
This randomized controlled clinical trial aims to evaluate the effectiveness of various therapies for treating Helicobacter pylori infection. Participants will receive different combinations of medications, including Rabeprazole, Bismuth potassium citrate, Metronidazole, Clarithromycin, and Levofloxacin. The goal is to determine the best treatment approach that not only ensures clinical efficacy but also minimizes antibiotic use. The trial will include patients aged 18-75 who have confirmed Helicobacter pylori infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a confirmed Helicobacter pylori infection.
Not a fit: Patients with severe comorbidities, active peptic ulcers, or those who have recently taken certain medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and less antibiotic-dependent treatments for Helicobacter pylori infection.
How similar studies have performed: Other studies have shown promise in evaluating various treatment regimens for Helicobacter pylori, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF). * 18-75 years old on the day of signing the ICF. * Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test. Exclusion Criteria: * Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. * Subjects or guardians refused to participate in the trial. * Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment. * Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment. * Pregnant or lactating women. * Active peptic ulcer. * allergic to drugs used in the trial. * any other circumstances that are not suitable for recruitment.
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Taotao Liu, MD — Fudan University
- Study coordinator: Qi Chen, MD
- Email: chenqimd@163.com
- Phone: 86-17811921405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.