Helicobacter Pylori Infection
Conditions
Keywords
Antimicrobial Susceptibility Testing, Rescue Therapy
Brief summary
The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.
Detailed description
Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection. The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.
Interventions
Patients will receive a 14-day quadruple therapy for the H.pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
DRUGone proton pump inhibitor, colloidal bismuth pectin
All patients need these two drugs.
DRUGtwo antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)
Patients will receive a 14-day quadruple therapy according to personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient hasn't been treated with levofloxacin previously, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-70 with persistent Helicobacter pylori infection. * Patients with previous Helicobacter pylori eradication therapy for one or two times.
Exclusion criteria
* Patients unable or unwilling to receive gastroscopy. * Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks. * Patients with gastrectomy, acute gastrointestinal 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 | 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 infection. 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 rates of adverse events happening | 6 months | Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process. |
| The rates of improving dyspepsia symptoms after helicobacter pylori eradication. | 6 months | Dyspepsia symptoms will also be measured using a 8-point Likert scale.be compared. Common adverse events will be measured using a 8-point Likert scale. Patients rate their symptoms from 0 (none) to 8 (severe) before and after the treatment process. |
| The rates of good compliance. | 6 months | Patients taken over 90% of drugs are considered to have a good compliance. |
Countries
China
Outcome results
None listed