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Completed

NCT Number: NCT05410652

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sanger Sequencing group

Diagnostic Test

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

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.

Primary outcomes

  1. Evaluation of consistency between fecal gene detection kit and Drug sensitivity test

    Time frame: 4 weeks

    Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and drug sensitivity test

  2. Evaluation of consistency between fecal gene detection kit and first generation sequencing

    Time frame: 4 weeks

    Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and first generation sequencing

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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