Helicobacter Pylori Infection, Antimicrobial Susceptibility Testing
Conditions
Keywords
Helicobacter Pylori Infection, Antimicrobial Susceptibility testing(AST)
Brief summary
The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.
Detailed description
Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies. Antimicrobial susceptibility test can pick out sensitive drugs to kill Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the first-line treatment. Our study aims to assess the efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection. Comparing this regimen with 14-day Empirical Tailored Therapy to tell which one is better in clinic practice. We also want to find whether the 10-day antimicrobial susceptibility test guided triple therapy has less intestinal dysbacteriosis with a shorter duration.
Interventions
Patients will receive a 10-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
DRUGtwo antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)
Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.
DRUGone proton pump inhibitor(PPI)
All the patients need this drug.
All the patients treated with 14-day bismuth-based quadruple therapy need this drug.
DRUGtwo antibiotics for failed eradication(tetracyclin,furazolidone)
If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-70 with H. pylori infection.
Exclusion criteria
* Patients with previous H. pylori eradication therapy; * Patients unable or unwilling to receive gastroscopy; * Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks; * Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; * Patients with known or suspected allergy to study medications; * Currently pregnant or lactating; * Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rates in 2 groups | 6 months | Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of improving dyspepsia symptoms after Helicobacter pylori eradication. | 6 months | Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication. |
| The rate of adverse events happening | 6 months | Similarly, adverse events will also be measured by the Likert scale. |
| The rate of good compliance | 6 months | Patients taken over 90% of drugs are considered to have a good compliance. |
| Difference of cost per patient for each eradication achieved in two groups | 6 months | — |
Countries
China
Contacts
Primary ContactXiuli Zuo, PhD,MD
Outcome results
None listed