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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410652
• Other study ID #: QX202200516-01
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: January 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1176
• Est. completion date: October 1, 2023
• Est. primary completion date: September 12, 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Disease Susceptibility
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

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.
• Sanger Sequencing group
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
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu
China	Jiangsu Taizhou People's Hospital	Taizhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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