Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT03383003
Brief Summary:
The Asian-Pacific Consensus Report has recommended that proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. As a general rule for the treatment of other infectious diseases, clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently. The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H. pylori. Clarithromycin resistance is the major cause of eradication failure for stand triple therapy. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol eradication rates of standard therapies are often less than 85% and the intention-to-treat eradication rates are usually less than 80%..7-10 day non-bismuth containing quadruple therapy (Concomitant therapy) had been successful in the presence of clarithromycin resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained \>90 eradication rate in some studies. This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0% in Taiwan . High dose PPI has been used in several studies for H. pylori eradication in order to increase the intra-gastric PH for optimal eradication So far, there is still unclear which one is the best first-line H. pylori eradication regimen with highest eradication rate and least adverse effects. We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies.
Detailed Description:
The Asian-Pacific Consensus Report has recommended that proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. As a general rule for the treatment of other infectious diseases, clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently.\[3-9\] The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H. pylori. The main reasons for eradication failure for H pylori infection include antibiotic resistance, poor compliance and rapid metabolism of PPI. Clarithromycin resistance is the major cause of eradication failure for stand triple therapy. The rate of clarithromycin-resistant strains ranged from 49% (Spain) to 1% (Netherland) worldwide. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol eradication rates of standard therapies are often less than 85% and the intention-to-treat eradication rates are usually less than 80%. 7-10 day non-bismuth containing quadruple therapy (Concomitant therapy) had been successful in the presence of clarithromycin resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained \>90 eradication rate in some studies. This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0% in Taiwan. High dose PPI has been used in several studies for H. pylori eradication in order to increase the intra-gastric PH for optimal eradication So far, there is still unclear which one is the best first-line H. pylori eradication regimen with highest eradication rate and least adverse effects. We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies.
Study:
NCT03383003
Study Brief:
Protocol Section:
NCT03383003