Status:
UNKNOWN
Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days
Lead Sponsor:
Shandong University
Collaborating Sponsors:
The Affiliated Hospital of Qingdao University
The People's Hospital of Guangrao
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 w...
Detailed Description
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent...
Eligibility Criteria
Inclusion
- Patients aged 18-65.
- Patients with H.pylori infection (Positive for any of the following: H.pylori culture, histopathology test, rapid urease test, 13C/14C-urea breath test, stool H.pylori antigen test).
- Patients whose birth place and residence within five years of birth are Shandong Province.
- Patients who have never received H. pylori eradication treatment.
Exclusion
- Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 3 times 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 whose current residence is not in Shandong Province.
- Patients whose re-check 13C/14C-urea breath test is negative before the start of the test.
- Patients who are unwilling or incapable to provide informed consents.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT04901117
Start Date
June 1 2021
End Date
August 1 2023
Last Update
May 25 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Qilu hosipital
Jinan, Shandong, China, 257000