drugset / Trial / NCT03897244

Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication

NCT03897244

RandomizedParallel-groupOpen-labelTreatment

Summary

Up to know, three is few large-scale, randomized study prospectively and simultaneously comparing the efficacy, adverse effects and patient compliance of high-dose dual therapy (HDDT) with or without bismuth versus amoxicillin-metronidazole bismuth quadruple therapy (AM-BQT) as first-line regimens for H. pylori eradication. The aims of this study are: 1. to compare the efficacy of HDDT with or without bismuth and AM-BQT as first-line regimens for H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens; 4. to identify the effect of H. pylori eradication on the evolution of ecosystem of microbiota, and inflammatory parameters.

Timeline

Start
2019-05-30
Primary completion
2025-02-11
Completion
2025-02-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 750 mg
Subject Amoxicillin Other / unclassified 1000 mg
Comparator Metronidazole Small molecule 500 mg
Subject Rabeprazole Small molecule 20 mg
Subject tripotassium dicitrate bismuthate Unknown 300 mg
Subject tripotassium dicitrate bismuthate Unknown 600 mg