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

Nanjing Medical University

Status: Completed

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

Treatments: Diagnostic Test: Bacterial culture and drug sensitivity test of gastric mucosa samples; Diagnostic Test: Detection of fecal samples with diagnostic kit; Diagnostic Test: Sanger Sequencing group

Study type: Observational

Funder types: Other

Identifiers

NCT05410652

QX202200516-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,176 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,176 participants in 3 patient groups

Fecal kit group

Description:

Collect stool samples from patients who meet the inclusion criteria. DNA was extracted from fecal samples. After that, the extracted DNA was sequenced by first generation sequencing. Finally，the mutation sites of extracted DNA were detected by fecal gene detection kit.

Treatment:

Diagnostic Test: Detection of fecal samples with diagnostic kit

Sanger Sequencing group

Description:

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

Treatment:

Diagnostic Test: Sanger Sequencing group

Drug sensitivity test group

Description:

Gastroscopy was performed on patients who met the inclusion and exclusion criteria to obtain samples of gastric mucosa. Helicobacter pylori culture and drug sensitivity test were performed on gastric mucosa samples in vitro. Finally, the drug sensitivity test results were collected.

Treatment:

Diagnostic Test: Bacterial culture and drug sensitivity test of gastric mucosa samples