High dose and frequency Extended-release Lansoprazole (Dexlansoprazole) and Amoxicillin dual therapy for Helicobacter pylori infections
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001758
- Lead Sponsor
- Kyungpook National University Medical Center
- Brief Summary
Background: Recently, the eradication rate of Helicobacter pylori infection worldwide has decreased to less than 80% with clarithromycin-based triple therapy due to the increased resistance of H. pylori to antibiotics, especially clarithromycin and metronidazole. Aims: The aim of our study was to determine the eradication rate of H. pylori infections following high and frequent doses of extended-release dexlansoprazole and amoxicillin as a dual therapy in an alternative trial in a region with high clarithromycin resistance. Methods: This prospective study included 50 treatment-naïve patients in our hospital with confirmed active H. pylori infections through rapid urease test or histology and serology between November 2015 and February 2016. All enrolled patients were treated with 750 mg amoxicillin and 30 mg dexlansoprazole four times daily for 14 days. Treatment success was examined by urea breath test four weeks after treatment completion. Results: Among 50 patients (29 men, 21 women; mean 57 years), 7 dropped out during the study. The total eradication rate was 52% (26/50). The eradication rate was 68.4% (26/38) in 38 patients with treatment compliance rates over 90%. H. pylori infections were not successfully eradicated in patients with compliance rates less than 90%. Nine patients (18%) reported side effects such as diarrhea and abdominal fullness and all had mild symptoms. No significant factors such as smoking and alcohol consumption affected the eradication rates. Conclusions: High and frequent dose proton pump inhibitor with amoxicillin dual therapy was not effective for the eradication of H. pylori infection in a province with high clarithromycin resistance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1) Either sex in age of 18 to 85
2) Among patients with active/inactive peptic ulcer diagnosed from endoscopy, those who have come up with benign helicobacter after an examination (a rapid urease test)
3) Among patients with no organic disorders from endoscopy but with indigestion, those who have been diagnosed with benign helicobacter after an examination (a rapid urease test) and those who are willing to get a bacteria-removal treatment
4) Among patients who received endoscopic mucosal resection or submucosal dissection to treat gastric adenoma or early gastric cancer, those with benign helicobacter diagnosed from an examination
5) Those who have signed a written subject consent to join the experimentation
1) Patients who have refused to participate in the experimentation
2) Patients who have been cured by the helicobacter eradication
3) Patients who have taken drugs for the last two weeks which would affect a bacteria examination and treatment (proton pump inhibitor, antibiotics, H2-receptor antagonist and bismuth)
4) Patients who are on steroids, aspirin and antithrombotic
5) Patients who have gone through a gastric operation (a gastric mucosal resection excluded)
6) Patients with severe heart disease, lung disease, hormonal disorder
7) Patients with severe problems in kidney and liver
8) Patients with blood disease
9) Patients with cancer
10) Expecting mother or patients with chances to be pregnant
11) Patients who have allergies to the test drug
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eradication rate
- Secondary Outcome Measures
Name Time Method safety and tolerability