Improving treatment for Helicobacter pylori infections with minocycline
Optimization of Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Multicentre, Randomized Controlled Trial
This study is testing a new treatment that combines minocycline with other medications to see if it can help people with stubborn Helicobacter pylori infections get better when standard treatments haven't worked.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 476 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 4 sites (Beijing, Beijing and 3 other locations) |
| Trial ID | NCT06561711 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and tolerability of a 14-day bismuth-containing quadruple rescue therapy that includes different dosages of minocycline and metronidazole for patients with refractory Helicobacter pylori infections. The goal is to optimize the minocycline-based regimen to achieve higher eradication rates while minimizing adverse events compared to classical bismuth quadruple therapy. Participants must have a confirmed H. pylori infection and prior treatment experience. The study aims to provide a more effective treatment option for patients who have not responded to standard therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed Helicobacter pylori infection who have previously undergone treatment.
Not a fit: Patients who are naive to H. pylori treatment, under 18 or over 80 years old, or have certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer treatment option for patients suffering from difficult-to-treat Helicobacter pylori infections.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific optimization of minocycline is a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection and with previous treatment experience Exclusion Criteria: * subjects naive to H. pylori treatment, * under 18 or over 80 years old * history of gastrectomy * pregnant or lactating women * Previous history of tuberculosis * Allergy to any of the study drugs * severe systemic diseases or malignancy * administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Where this trial is running
Beijing, Beijing and 3 other locations
- Peking University Third Hospital — Beijing, Beijing, China (Recruiting)
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai, China (Recruiting)
- Songjiang Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai, China (Recruiting)
- The Second Affiliated Hospital of Zhejiang University school of Medicine — Hangzhou, Zhejiang, China (Recruiting)
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.