MedTrace Logo

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

NCT05410652 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1176

Last updated 2024-01-30

No results posted yet for this study

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

Interventions

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.

DIAGNOSTIC_TEST

Sanger Sequencing group

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

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.

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Principal Investigators

  • Zhenyu Zhang, Master · Nanjing First Hospital, Nanjing Medical University

  • Yong Xie, Docter · The First Affiliated Hospital of Nanchang University

  • Bin lv, Master · The First Affiliated Hospital of Zhejiang Chinese Medical University

  • Bin Yang, Doctor · Jiangsu Taizhou People's Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-09-12
Completion
2023-10-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05410652 on ClinicalTrials.gov