Gastric Ulcer, Gastritis
Conditions
Keywords
Helicobacter pylori, Antibiotic resistance, Sequencing, Mechanism, Cause
Brief summary
Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out with the goal of improving H. pylori eradication and therapies have changed from single-antibiotic treatments to the current multi-antibiotic treatments. However, the eradication rate of H. pylori is still less than 80%. The reasons for this low eradication rate are likely to be multi-factorial, including the reduced activity of antimicrobial drugs, poor patient compliance or micro-environment in stomach. In this study, to obtain the higher eradication of H. pylori and discover the different mechanism between the current infection and refractory infection of H. pylori, it is necessary to perform a prevalence survey for eradication of H. pylori based on the results from isolation of H. pylori strains, antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.
Interventions
BIOLOGICALAntibiotic selection based on the antibiotic susceptibility testing
The biological intervention focused on the results from the antibiotic susceptibility testing. All patients should used the their susceptibility antibiotics according to antibiotic susceptibility testing of H. pylori. Considering the safety of drug usage, priority antibiotic selection was as follow: Amoxicillin \> Clarithromycin \> Levofloxacin \>Tetracycline \> Furazolidone \> Metronidazole.
GENETICPPI selection based on the CYP2C19 gene polymorphism
PPI selection should based on the CYP2C19 gene polymorphism of patients. Patients have different metabolizers, such as poor metabolizers (PM), extensive metabolizers (EM) and intermediate metabolizer (IM). Different metabolism of patients should select different PPI or different doses of PPI. For IM and PM, in this study, patients selected the standard dose of Omeprazole. For EM, in this study, patients selected the Esomeprazole with increasing doses 50%-100%.
DIETARY_SUPPLEMENTProbiotics usage based on the 16SrRNA sequencing
Different micro-environment in stomach may influence the antibiotic absorption. In this study, some patients could select probiotic as adjuvant therapy according to their micro-environment in stomach by 16SrRNA sequencing.
Sponsors
Peking Union Medical College Hospital
Nanfang Hospital, Southern Medical University
Third Affiliated Hospital of Third Military Medical University
The First Affiliated Hospital with Nanjing Medical University
Centers for Disease Control and Prevention, China
Academy Military Medical Science, China
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\ 70 years old, male or female, untreated patients. 2. Symptoms of abdominal pain, bloating, acid reflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc. 3. Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks 4. 13C-labelled urea breath test positive. 5.Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive. 6.Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.
Exclusion criteria
1. Severe heart, liver, kidney dysfunction. 2. Pregnant or lactating women. 3. Complications of bleeding, perforation, pyloric obstruction, cancer. 4. Esophageal,gastrointestinal surgery history. 5. Patients can not properly express their complaints,such as psychosis, severe neurosis. 6. Taking NSIAD or alcohol abusers. 7. Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rates | Three months | To investigate the eradication rates of H.Pylori after individual quadruple therapy based on antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing. |
| Mutation site of drug resistance gene | Three months | To discover the difference of mutation site in drug resistance gene between successful patients and refractory patients by second-generation sequencing. |
| The distribution and proportion of microflora in stomach | Three months | To discover the distribution and proportion of microflora in stomach between successful patients and refractory patients of H. Pylori infection by 16SrRNA sequencing. |
Contacts
Primary ContactYouming Li, professor
Outcome results
None listed