NCT04660123

A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 959 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe the eradication rate of H. pylori infection, symptom improvement and the incidence of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy.

Detailed description

The study will include three phases: screening, treatment and follow-up. Screening: Patients who have been screened to meet the criteria for naval platooning will be enrolled after signing an informed consent form. Treatment: Subjects will receive 14 days of eradication treatment. With the exception of colloidal bismuth pectin granules, which will be limited, proton pump inhibitors (PPI) and 2 antibiotics will be selected on the basis of the physician's experience. 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 Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication	Standard dose of proton pump inhibitor, bismuth , and 2 antibiotics, 14 days course. Standard doses of proton pump inhibitors are esomeprazole 20mg, rabeprazole 10mg (or 20mg). Omeprazole 20mg, lansoprazole 30mg, pantoprazole 40mg, alprazole 5mg, any one of these. Bismuth is colloidal bismuth pellets, 150mg, 2 times/d. Antibiotic Program: Scheme 1 Amoxicillin 1000 mg, 2 times/d; Clarithromycin 500mg, 2 times per day Scheme 2 Amoxicillin 1000 mg, 2 times/d; Levofloxacin 5001 times/2 times Scheme 3 Amoxicillin 1000 mg, 2 times/d; Furazolidone 100mg, 2 times/d. Scheme 4 Amoxicillin 1000 mg, 2 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 5 Amoxicillin 1000 mg, 2 times/d; Tetracycline 500mg, 3 times/d or 4 times/d Scheme 6 Tetracycline 500mg, 3 times/d or 4 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 7 Tetracycline 500mg, 3 times/d or 4 times/d; Furazolidone 100mg, 2 times/d.

Timeline

• Start date: 2020-12-20
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-12-09
• Last updated: 2023-01-31

Locations

1 site across 1 country: China