Using doxycycline to treat Helicobacter pylori infections
Doxycycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
This study is testing if a new 14-day treatment using doxycycline can effectively help people with Helicobacter pylori infections who haven't responded to previous treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 368 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05874570 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and tolerability of a 14-day treatment regimen for Helicobacter pylori infections, replacing tetracycline with doxycycline in a bismuth-containing quadruple therapy. The aim is to address the limitations of current treatment guidelines, particularly in regions where tetracycline is unavailable and where adverse effects from existing therapies lead to poor patient compliance. Participants will include individuals with confirmed H. pylori infections who have previously failed treatment. The study will assess both the efficacy of the new regimen and its safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed Helicobacter pylori infections who have experienced treatment failure.
Not a fit: Patients who are naive to H. pylori treatment or have severe systemic diseases or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more tolerable and effective option for patients with Helicobacter pylori infections.
How similar studies have performed: While this approach is novel in the context of replacing tetracycline with doxycycline in this specific treatment regimen, similar studies have shown varying degrees of success with alternative therapies for Helicobacter pylori.
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 failure Exclusion Criteria: * subjects naive to H. pylori treatment, * under 18 or over 80 years old * history of gastrectomy * pregnant or lactating women * 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
Shanghai, Shanghai Municipality
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, 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.