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

NCT05410652 | Completed

• 1 other identifier: QX202200516-01
• Study Type: observational
• Target: 1,176
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Fecal gene detection; Levofloxacin resistance gene; Clarithromycin resistance gene

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

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

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

Interventions

Detection of fecal samples with diagnostic kit DIAGNOSTIC_TEST

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

Fecal kit group

Sanger Sequencing group DIAGNOSTIC_TEST

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

Sanger Sequencing group

Bacterial culture and drug sensitivity test of gastric mucosa samples DIAGNOSTIC_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.

Drug sensitivity test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. patients with Helicobacter pylori infection who need gastroscopy; 2. patients with positive Helicobacter pylori culture in gastric mucosa 3. Helicobacter pylori negative patients

You may not qualify if:

• Patients with insufficient fecal samples collected 2.Patients with contraindication of gastroscopic biopsy

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (4)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Jiangsu Taizhou People's Hospital

Taizhou, Jiangsu, 225300, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• Wei WJ, He BS, Lv B, Yang B, Xie Y, Zhang ZY. Clinical evaluation of a novel H. pylori fecal molecular diagnosis kit (multiplex RT-PCR method) for detecting clarithromycin and fluoroquinolones resistance using stool samples. Front Cell Infect Microbiol. 2025 Jun 23;15:1592612. doi: 10.3389/fcimb.2025.1592612. eCollection 2025.

  PMID: 40625832 DERIVED

Study Officials

• Zhenyu Zhang, Master

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

• Yong Xie, Docter

  The First Affiliated Hospital of Nanchang University

  STUDY DIRECTOR

• Bin lv, Master

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  STUDY DIRECTOR

• Bin Yang, Doctor

  Jiangsu Taizhou People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior professional title

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 8, 2022
• Study Start: August 1, 2022
• Primary Completion: September 12, 2023
• Study Completion: October 1, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)