Helicobacter pylori infection
Conditions
Interventions
Gold Standard:1. The positive criteria for Hp infection: (1) The histological staining result from gastric mucosa tissue biopsy is positive
(2) The 13C breath test is positive (DOB value >= 6)
(3) The rapid urease test of gastric mucosa tissue is positive. If (1) or (2) + (3) are met, it indicates Hp infection.
2. The negative criteria for Hp infection: (1) The histological staining result
(2) The 13C breath test is positive (DOB value < 4)
(3) The rapid urease test of gastric mucosa tissue is negative. If (1) + (2) + (3) are met, it indicates Hp is negative.
Index test:The steps for gastric mucosa lavage and extraction of lavage fluid are as follows: 1. Remove the gastric fluid under the gastroscopy and store it for later use
2. Clean the biopsy channel (inject sterile distilled water through the biopsy channel and press the endoscope suction button simultaneously)
3. Inject 20 ml of sterile distilled water through the biopsy channel, leaving it for 1-2 minutes (during this period, endoscopic observation of the gastric mucosa and duodenal mucosa can be completed
4. Under the gastroscopy, aspirate and collect the sterile distilled water (lavage fluid) injected into the stomach through the biopsy channel and store it for preservation and submission for testing.
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 to 70 years old; 2. Patients presenting with symptoms related to gastritis and/or dyspepsia such as abdominal pain, abdominal distension, belching, hiccups, and nausea; 3. Participants who agreed to complete gastroscopy, rapid urease test, gastric mucosa histological examination, urea breath test, gastric mucosa tissue RT-PCR method for HP detection, and gastric fluid RT-PCR method for HP detection at the time of enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients who had taken antibiotics, bismuth preparations, or proton pump inhibitors orally within 1 month before enrollment; 2. Patients with active upper gastrointestinal bleeding; 3. Patients with clear contraindications to endoscopic examination; 4. Patients with a long-term history of heavy alcohol consumption or drug abuse, or those who have had a history of glucocorticoid medication for a long time or recently; 5. Pregnant or lactating patients; 6. Patients who had participated in other clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnositic efficacy of H. pylori infection based on gastric lavage fluid specimens; | — |
Secondary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of gastric lavage fluid specimens for diagnosing clarithromycin resistance, fluoroquinolone resistance, and metronidazole resistance;The correlation between the HP bacterial content in gastric fluid and gastric lavage fluid and inflammation of gastric mucosal; | — |
Countries
China
Contacts
Public ContactXiaobei Si
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed