NCT05874570 Doxycycline for Helicobacter Pylori Rescue Treatment
| NCT ID | NCT05874570 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 368 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2025-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 368 participants in total. It began in 2023-06-20 with a primary completion date of 2025-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by doxycycline.
Eligibility 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
Frequently Asked Questions
Who can join the NCT05874570 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05874570 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05874570 currently recruiting?
Yes, NCT05874570 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Jiao Tong University School of Medicine to inquire about joining.
Where is the NCT05874570 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05874570 clinical trial?
NCT05874570 is sponsored by Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 368 participants.