Status:
RECRUITING
Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)
Lead Sponsor:
Shandong University
Collaborating Sponsors:
Zibo Maternal and Child Health Hospital
Zaozhuang Municipal Hospital
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of gastric cancer...
Detailed Description
Related studies have shown that 7-day bismuth quadruple therapy is not inferior to 14-day bismuth quadruple therapy in the eradication of clarithromycin-resistant H. pylori.The results of the current ...
Eligibility Criteria
Inclusion
- Patients aged 18-70.
- Without active hepatitis.
- Helicobacter pylori infection (either positive for rapid urease test, C13/C14 urea breath test).
- Patients who have not previously received helicobacter pylori eradication therapy.
Exclusion
- 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%.
- Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
- Patients with active gastrointestinal bleeding.
- Patients with a history of upper gastrointestinal surgery.
- Patients allergic to treatment drugs.
- Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks.
- Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse.
- Patients who are unwilling or incapable to provide informed consents.
Key Trial Info
Start Date :
September 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT05997433
Start Date
September 2 2023
End Date
August 30 2024
Last Update
January 11 2024
Active Locations (1)
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1
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012