Helicobacter Pylori InfectionNCT04923113
Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis
A study testing Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pylori and Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectin in people with Helicobacter Pylori Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
As we know，Helicobacter pylori is closely related to many gastrointestinal diseases such as chronic gastritis, peptic ulcer disease,gastric carcinoma and gastric mucosa-associated lymphoid tissue lymphoma，as well as extra-digestive diseases such as urticaria and chronic obstructive pulmonary diseases and so on.The… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pylori and Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 2 sitesChina
- Study dates
- 28 Jun 2021to 18 Jan 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants was confirmed chronic atrophic gastritis by endoscopy
- participants has not been previously received treatment for H.pylori infection.
Who cannot join
- patients who were allergic to any study medications
- patients who had taken antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA) 4 weeks before the study
- patients with previous gastrectomy
- patients with malignancy or severe comorbidity
- pregnant or lactating women
- Patients with poor treatment compliance or could not express themselves correctly
- patients who participated in other drug trial recently (within 3 months of enrollment).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
As we know，Helicobacter pylori is closely related to many gastrointestinal diseases such as chronic gastritis, peptic ulcer disease,gastric carcinoma and gastric mucosa-associated lymphoid tissue lymphoma，as well as extra-digestive diseases such as urticaria and chronic obstructive pulmonary diseases and so on.The diagnosis of H. pylori infection is based on invasive methods requiring endoscopy and biopsy(e.g. histology, culture, rapid urease test, PCR) or on non-invasive methods (e.g. serology, 13C urea breath test, stool antigen test).Histology has the highest specificity among the others,and also allows us to determine the underlying disease and perform antibiotic sensitivity testing.Serological tests are widely available and more appropriate for epidemiological studies, their main weakness for clinical use is low specificity.The 13C urea breath test is the most accurate method in patients irrespective of age.Stool antigen testing,as a promising method, is easy to perform, and its accuracy may be improved by the use of monoclonal antibodies recently proposed for capturing H. pylori antigen in stool specimen.Sensitivity and specificity, usefulness,and limitation of tests should be considered for selection of detection methods of H. pylori. Our objective is to review the current methods that are used for the detection of H. pylori infection among patients with chronic atrophic gastritis.Except that,patients with Hp positive will be further treated with 10-day minocycline-based quadruple therapy,to observe the efficacy and safety of minocycline-based regimen for H.pylori eradication as a first-line therapy.
Read the detailed description
Consecutive outpatients (18 to 70 years), with endoscopically proven chronic atrophic gastritis will be enrolled in our study.5 different methods，including histology,13C urea breath test,stool antigen test,serological antibody test for H.pylori and serologic test with a current infection marker of H.pylori，will be performed to detect H. pylori infection.And patients with Hp positive will be further treated with 10-day minocycline-based quadruple therapy.Our objective is to compare specificity and sensitivity of the current methods among patients with chronic atrophic gastritis,meanwhile,to observe the efficacy and safety of minocycline-based regimen for H.pylori eradication as a first-line therapy.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pylori, Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pyloriDiagnostic test
The above 5 detection methods will be performed in patients who meet the inclusion criteria to detect H. pylori infection
Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectinDrug
Helicobacter pylori positive patients will be treated with rabeprazole10mg,minocycline 100mg,amoxicillin1000mg,and colloidal bismuth pectin 200mg,all twice daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| patients who meet the inclusion criteria | Experimental | 5 different methods will be performed to detect H. pylori infection in patients who meet the inclusion criteria，and patients with Hp positive will be further treated with 10-day minocycline-based quadruple therapy,to observe the efficacy and safety of minocycline-based regimen for H.pylori eradication as a first-line therapy. Receives: Diagnostic Test: Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pylori; Drug: Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of different Helicobacter pylori detection methods
H.pylori infection status will be confirmed by 5 different methods,including histology,13C-UBT,stool antigen test,serological antibody test for H.pylori and serologic test with a current infection marker of H.pylori therapy.
Measured: 5 days
Secondary outcomes (1)
the efficacy of minocycline-based bismuth quadruple therapy for H.pylori eradication as a first-line therapy
patients with Hp positive（confirmed by either histology or13C-UBT） will be further treated with 10-day minocycline-based quadruple therapy.The eradication of H.pylori will be confirmed by negative 13C-or 14C-UBT 4~12 weeks after therapy.
Measured: 5.5~13.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start28 Jun 2021
- Primary completion31 Jan 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue-Hua Han, PhD, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923113
- Sponsor's protocol ID
- 2021-0290
- Status last verified
- May 2021
- First submitted
- 30 May 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis
- ClinicalTrials.gov ID
- NCT04923113
- Acronym / sponsor ID
- 2021-0290
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 11 Jun 2021 (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.
As we know，Helicobacter pylori is closely related to many gastrointestinal diseases such as chronic gastritis, peptic ulcer disease,gastric carcinoma and gastric mucosa-associated lymphoid tissue lymphoma，as well as extra-digestive diseases such as urticaria and chronic obstructive pulmonary diseases and so on.The diagnosis of H. pylori infection is based on invasive methods requiring endoscopy and biopsy(e.g. histology, culture, rapid urease test, PCR) or on non-invasive methods (e.g. serology, 13C urea breath test, stool antigen test).Histology has the highest specificity among the others,and also allows us to determine the underlying disease and perform antibiotic sensitivity testing.Serological tests are widely available and more appropriate for epidemiological studies, their main weakness for clinical use is low specificity.The 13C urea breath test is the most accurate method in patients irrespective of age.Stool antigen testing,as a promising method, is easy to perform, and its accuracy may be improved by the use of monoclonal antibodies recently proposed for capturing H. pylori antigen in stool specimen.Sensitivity and specificity, usefulness,and limitation of tests should be considered for selection of detection methods of H. pylori. Our objective is to review the current methods that are used for the detection of H. pylori infection among patients with chronic atrophic gastritis.Except that,patients with Hp positive will be further treated with 10-day minocycline-based quadruple therapy,to observe the efficacy and safety of minocycline-based regimen for H.pylori eradication as a first-line therapy.
Detailed description
Consecutive outpatients (18 to 70 years), with endoscopically proven chronic atrophic gastritis will be enrolled in our study.5 different methods，including histology,13C urea breath test,stool antigen test,serological antibody test for H.pylori and serologic test with a current infection marker of H.pylori，will be performed to detect H. pylori infection.And patients with Hp positive will be further treated with 10-day minocycline-based quadruple therapy.Our objective is to compare specificity and sensitivity of the current methods among patients with chronic atrophic gastritis,meanwhile,to observe the efficacy and safety of minocycline-based regimen for H.pylori eradication as a first-line therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who meet the inclusion criteria | Experimental | Diagnostic Test: Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pylori, Drug: Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectin5 different methods will be performed to detect H. pylori infection in patients who meet the inclusion criteria，and patients with Hp positive will be further treated with 10-day minocycline-based quadruple therapy,to observe the efficacy and safety of minocycline-based regimen for H.pylori eradication as a first-line therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participants was confirmed chronic atrophic gastritis by endoscopy
- participants has not been previously received treatment for H.pylori infection.
Key exclusion criteria (7 listed)
- patients who were allergic to any study medications
- patients who had taken antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA) 4 weeks before the study
- patients with previous gastrectomy
- patients with malignancy or severe comorbidity
- pregnant or lactating women
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 |
|---|---|---|
| Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pyloriThe above 5 detection methods will be performed in patients who meet the inclusion criteria to detect H. pylori infection | Diagnostic test | patients who meet the inclusion criteria |
| Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectinHelicobacter pylori positive patients will be treated with rabeprazole10mg,minocycline 100mg,amoxicillin1000mg,and colloidal bismuth pectin 200mg,all twice daily for 10 days | Drug | patients who meet the inclusion criteria |
Primary outcome
Sensitivity and specificity of different Helicobacter pylori detection methods
Time frame: 5 days
H.pylori infection status will be confirmed by 5 different methods,including histology,13C-UBT,stool antigen test,serological antibody test for H.pylori and serologic test with a current infection marker of H.pylori therapy.
1 secondary outcome
the efficacy of minocycline-based bismuth quadruple therapy for H.pylori eradication as a first-line therapy
Time frame: 5.5~13.5 weeks
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 24 Feb 2023.
- 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.
Yue-Hua Han, PhD study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pylori and Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectin in people with Helicobacter Pylori Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 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 2 inclusion and 7 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 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Sensitivity and specificity of different Helicobacter pylori detection methods (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2023.