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

Completed

• Conditions: Fecal Drug Resistance Gene Detection; Helicobacter Pylori Infection, Susceptibility to; Helicobacter Pylori gyrA Levofloxacin Resistance Mutation; Helicobacter Pylori Infection
• Interventions: Diagnostic Test: Sanger Sequencing group; Diagnostic Test: Bacterial culture and drug sensitivity test of gastric mucosa samples; Diagnostic Test: Detection of fecal samples with diagnostic kit

• Registration Number: NCT05410652
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-05
• Study First Posted: 2022-06-08
• Study Start: 2022-08-01
• Primary Completion: 2023-09-12
• Study Completion: 2023-10-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-27
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1176

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sanger Sequencing group	Sanger Sequencing group	Detection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing
Drug sensitivity test group	Bacterial culture and drug sensitivity test of gastric mucosa samples	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.
Fecal kit group	Detection of fecal samples with diagnostic kit	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of consistency between fecal gene detection kit and first generation sequencing	4 weeks	Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and first generation sequencing
Evaluation of consistency between fecal gene detection kit and Drug sensitivity test	4 weeks	Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and drug sensitivity test

Trial Locations

Locations (4)

The First Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China

Jiangsu Taizhou People's Hospital; 🇨🇳 Taizhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Nanjing First Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China