NCT06723197 Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication
| NCT ID | NCT06723197 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shandong University |
| Condition | HELICOBACTER PYLORI INFECTIONS |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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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 330 participants in total. It began in 2024-12-10 with a primary completion date of 2025-10-01.
⚠ 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
The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18-70 years old 2. Patients with H.pylori infection (13C/14C-urea breath test) 3. Patients without previous treatment for H. pylori eradication Exclusion Criteria: 1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75% 2. Patients with active gastrointestinal bleeding 3. Patients with a history of upper gastrointestinal surgery 4. Patients allergic to treatment drugs 5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks 6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial 7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse 8. Patients who are unwilling or incapable to provide informed consents
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06723197 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying HELICOBACTER PYLORI INFECTIONS. 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 NCT06723197 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 NCT06723197 currently recruiting?
Yes, NCT06723197 is actively recruiting participants. Contact the research team at liyanqing@sdu.edu.cn for enrollment information.
Where is the NCT06723197 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06723197 clinical trial?
NCT06723197 is sponsored by Shandong University. The trial plans to enroll 330 participants.