Helicobacter Pylori InfectionNCT05410652
Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)
An observational study of Helicobacter Pylori Infection and Helicobacter Pylori gyrA Levofloxacin Resistance Mutation, run by Nanjing First Hospital, Nanjing Medical University at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection, Helicobacter Pylori gyrA Levofloxacin Resistance Mutation, Fecal Drug Resistance Gene Detection
- What is being tested?
- Detection of fecal samples with diagnostic kit, Sanger Sequencing group and Bacterial culture and drug sensitivity test of gastric mucosa samples
- How many people
- 1,176 participants
- Where
- 4 sitesChina
- Study dates
- 1 Aug 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: This study will collect patients aged 18-70 years with or without Helicobacter pylori infection who have the need for gastroscopy.
Who may be able to join
- 1. patients with Helicobacter pylori infection who need gastroscopy; 2. patients with positive Helicobacter pylori culture in gastric mucosa 3. Helicobacter pylori negative patients
Who cannot join
- 1.Patients with insufficient fecal samples collected 2.Patients with contraindication of gastroscopic biopsy
Trial locations and contacts
4 sites in 1 country.
China4 sites
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310003
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, 225300
About this study
Official title: A Multicenter Clinical Study of 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.
Read the 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
- Being tested
- Detection of fecal samples with diagnostic kit, Sanger Sequencing group, Bacterial culture and drug sensitivity test of gastric mucosa samples
- Keywords
- Fecal gene detection, Levofloxacin resistance gene, Clarithromycin resistance gene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of fecal samples with diagnostic kitDiagnostic 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 groupDiagnostic 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 samplesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Detection of fecal samples with diagnostic kit | |
| Sanger Sequencing group | Detection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing Receives: Diagnostic Test: Sanger Sequencing group | |
| 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. Receives: Diagnostic Test: Bacterial culture and drug sensitivity test of gastric mucosa samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Aug 2022
- Primary completion12 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,176 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Zhenyu Zhang, Master, Study chair, Nanjing First Hospital, Nanjing Medical UniversityYong Xie, Docter, Study director, The First Affiliated Hospital of Nanchang UniversityBin lv, Master, Study director, The First Affiliated Hospital of Zhejiang Chinese Medical UniversityBin Yang, Doctor, Principal investigator, Jiangsu Taizhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410652
- Sponsor's protocol ID
- QX202200516-01
- Status last verified
- Jan 2024
- First submitted
- 5 Jun 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40625832
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)
- ClinicalTrials.gov ID
- NCT05410652
- Acronym / sponsor ID
- QX202200516-01
- Conditions
- Helicobacter Pylori Infection, Helicobacter Pylori gyrA Levofloxacin Resistance Mutation, Fecal Drug Resistance Gene Detection, Helicobacter Pylori Infection, Susceptibility to
- Keywords
- Fecal gene detection, Levofloxacin resistance gene, Clarithromycin resistance gene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,176 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fecal kit group | – | Diagnostic Test: Detection of fecal samples with diagnostic kitCollect 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. |
| Sanger Sequencing group | – | Diagnostic Test: Sanger Sequencing groupDetection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing |
| Drug sensitivity test group | – | Diagnostic Test: Bacterial culture and drug sensitivity test of gastric mucosa samplesGastroscopy 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will collect patients aged 18-70 years with or without Helicobacter pylori infection who have the need for gastroscopy.
Key inclusion criteria (1 listed)
- 1. patients with Helicobacter pylori infection who need gastroscopy; 2. patients with positive Helicobacter pylori culture in gastric mucosa 3. Helicobacter pylori negative patients
Key exclusion criteria (1 listed)
- 1.Patients with insufficient fecal samples collected 2.Patients with contraindication of gastroscopic biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of fecal samples with diagnostic kitThe 23S rRNA mutation site of clarithromycin and gyrA mutation site of levofloxacin were detected by Helicobacter Pylori fecal Gene Mutation Detection Kit. | Diagnostic test | Fecal kit group |
| Sanger Sequencing groupDetection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing | Diagnostic test | Sanger Sequencing group |
| Bacterial culture and drug sensitivity test of gastric mucosa samplesFirst, 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. | Diagnostic test | Drug sensitivity test group |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 40625832Wei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenyu Zhang, Master study chair
Nanjing First Hospital, Nanjing Medical University
Yong Xie, Docter study director
The First Affiliated Hospital of Nanchang University
Bin lv, Master study director
The First Affiliated Hospital of Zhejiang Chinese Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Helicobacter Pylori gyrA Levofloxacin Resistance Mutation, run by Nanjing First Hospital, Nanjing Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of consistency between fecal gene detection kit and Drug sensitivity test (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.