Trials / Completed
CompletedNCT05410652
Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)
A Multicenter Clinical Study of Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,176 (actual)
- Sponsor
- Nanjing First Hospital, Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2023-09-12
- Completion
- 2023-10-01
- First posted
- 2022-06-08
- Last updated
- 2024-01-30
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05410652. Inclusion in this directory is not an endorsement.