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

NCT ID: NCT05410652

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1176 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-10-01

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Detection of fecal samples with diagnostic kit

Intervention Type: 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.

Sanger Sequencing group

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

Sanger Sequencing group

Intervention Type: DIAGNOSTIC_TEST

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

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.

Bacterial culture and drug sensitivity test of gastric mucosa samples

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Sanger Sequencing group

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

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhenyu Zhang

Senior professional title

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenyu Zhang, Master

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Yong Xie, Docter

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Nanchang University

Bin lv, Master

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Zhejiang Chinese Medical University

Bin Yang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Taizhou People's Hospital

Locations

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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40625832 (View on PubMed)

Other Identifiers

QX202200516-01

Identifier Type: -

Identifier Source: org_study_id