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

A Multicenter Clinical Study of Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 1176

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing First Hospital, Nanjing Medical University
    • Taizhou, Jiangsu, China, 225300
      • Jiangsu Taizhou People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The First Affiliated Hospital Of Nanchang University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

This study will collect patients aged 18-70 years with or without Helicobacter pylori infection who have the need for gastroscopy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fecal kit group; 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.	Diagnostic test: Detection of fecal samples with diagnostic kit; The 23S rRNA mutation site of clarithromycin and gyrA mutation site of levofloxacin were detected by Helicobacter Pylori fecal Gene Mutation Detection Kit.
Drug sensitivity test group; 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.	Diagnostic test: Bacterial culture and drug sensitivity test of gastric mucosa samples; 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.
Sanger Sequencing group; Detection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing	Diagnostic test: Sanger Sequencing group; Detection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	4 weeks

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Zhenyu Zhang, Master, Nanjing First Hospital, Nanjing Medical University; Study Director: Yong Xie, Docter, The First Affiliated Hospital Of Nanchang University; Study Director: Bin lv, Master, The First Affiliated Hospital of Zhejiang Chinese Medical University; Principal Investigator: Bin Yang, Doctor, Jiangsu Taizhou People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Fecal gene detection; Levofloxacin resistance gene; Clarithromycin resistance gene
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Disease Susceptibility; Helicobacter Infections
• Other Study ID Numbers: QX202200516-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No