Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Collaborators: Heze Municipal 3rd people's hospital; Jining No.2 People's Hospital; Maternity and Child Care Health Center of Dezhou; PKUcare luzhong hospital; Qihe County City Hospital; Qilu Hospital of Shandong University; Shandong Electric Power Central Hospital; Shandong Provincial Third Hospital; Taian City Central Hospital; The Affiliated Hospital of Qingdao University; The People's Hospital of Guangrao; Weifang People's Hospital; Weihai Municipal Hospital; Yuncheng Chengxin Hospital; Zoucheng People's Hospital
• Treatments: Amoxicillin; Bismuth; Clarithromycin; Metronidazole; Potassium Citrate; Tetracycline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.