H.Pylori Gastrointestinal Disease Clinical Trial
Official title:
Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication
It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP),
7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one
PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7
or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.
This study aims to investigate which duration would be better for eradication of HP. The
study design is a randomized controlled trial. The patients were randomly assigned to 7 days
or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple
therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in
both groups.
The recommended duration of triple therapy is typically 10 to 14 days in the United States
and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or
14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI
and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is
often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole,
bismuth-based quadruple therapy is commonly used as second-line therapy, however, the
eradication rates was widely ranged according to the treatment duration.
The objective of the study is to investigate whether treatment duration would affect the
eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based
quadruple therapy (2nd line therapy).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03592069 -
Concomitant Versus Hybrid Regimen for H. Pylori Eradication
|
Phase 4 | |
| Recruiting |
NCT05577572 -
Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic
|
N/A |