NCT04209933

Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

Comparison of Efficacy of Bismuth Potassium Citrate, Pectin Bismuth Capsules, and Pectin Bismuth Granules in the Treatment of Helicobacter Pylori (Hp) First-line Quadruple Regimen: a Multicenter, Randomized, Prospective, Comparative Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare efficacy and safety of bismuth-containing quadruple therapy（with rabeprazole amoxicillin clarithromycin）of different kinds of bismuth（Bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles）in H. pylori first-line eradication. It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

Detailed description

The study will include three phases: screening, treatment and follow-up.Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Conditions

• Gastric Cancer
• Helicobacter Pylori Infection
• Bismuth

Interventions

Type	Name	Description
DRUG	Bismuth potassium citrate containing quadruple therapy	Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
DRUG	Colloidal pectin bismuth capsules containing quadruple therapy	Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
DRUG	Colloidal pectin bismuth particles A quadruple therapy	Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
DRUG	Colloidal pectin bismuth particles B quadruple therapy	Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Timeline

• Start date: 2020-05-25
• Primary completion: 2020-08-01
• Completion: 2020-08-30
• First posted: 2019-12-24
• Last updated: 2021-04-08

Locations

1 site across 1 country: China