Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)

Nanjing First Hospital, Nanjing Medical University1,176 enrolled

Overview

The purpose of this study was to evaluate the detection ability of Helicobacter pylori 23S rRNA/gyrA gene mutation detection kit (fluorescent PCR fusion curve method) for Helicobacter pylori gene mutation.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requriment will be included in this simultaneous blind test.

Study Type

OBSERVATIONAL

Enrollment

1,176

Conditions

Helicobacter Pylori Infection Helicobacter Pylori gyrA Levofloxacin Resistance Mutation Fecal Drug Resistance Gene Detection Helicobacter Pylori Infection, Susceptibility to

Interventions

Detection of fecal samples with diagnostic kitDIAGNOSTIC_TEST

The 23S rRNA mutation site of clarithromycin and gyrA mutation site of levofloxacin were detected by Helicobacter Pylori fecal Gene Mutation Detection Kit.

Sanger Sequencing groupDIAGNOSTIC_TEST

Detection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing

Bacterial culture and drug sensitivity test of gastric mucosa samplesDIAGNOSTIC_TEST

First, a sample of the patient's gastric mucosa will be obtained through gastroscopy. Then, Helicobacter pylori culture and drug sensitivity test can be carried out. Finally, the resistance data of Helicobacter pylori to clarithromycin and levofloxacin will be obtained.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. patients with Helicobacter pylori infection who need gastroscopy; 2. patients with positive Helicobacter pylori culture in gastric mucosa 3. Helicobacter pylori negative patients Exclusion Criteria: * 1.Patients with insufficient fecal samples collected 2.Patients with contraindication of gastroscopic biopsy

Locations (4)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Jiangsu Taizhou People's Hospital

Taizhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Evaluation of consistency between fecal gene detection kit and Drug sensitivity test

Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and drug sensitivity test

Time frame: 4 weeks

Evaluation of consistency between fecal gene detection kit and first generation sequencing

Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and first generation sequencing

Time frame: 4 weeks

Data from ClinicalTrials.gov

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