Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis
Primary Purpose
Helicobacter Pylori Infection
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional diagnostic trial for Helicobacter Pylori Infection
Eligibility Criteria
Inclusion Criteria:
- participants was confirmed chronic atrophic gastritis by endoscopy
- participants has not been previously received treatment for H.pylori infection.
Exclusion Criteria:
- 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).
Sites / Locations
- Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine
- Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients who meet the inclusion criteria
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04923113
First Posted
May 30, 2021
Last Updated
February 22, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04923113
Brief Title
Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis
Official Title
Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
281 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients who meet the inclusion criteria
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
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
Intervention Description
The above 5 detection methods will be performed in patients who meet the inclusion criteria to detect H. pylori infection
Intervention Type
Drug
Intervention Name(s)
Rabeprazole,Minocycline,Amoxicillin and Colloidal bismuth pectin
Intervention Description
Helicobacter pylori positive patients will be treated with rabeprazole10mg,minocycline 100mg,amoxicillin1000mg,and colloidal bismuth pectin 200mg,all twice daily for 10 days
Primary Outcome Measure Information:
Title
Sensitivity and specificity of different Helicobacter pylori detection methods
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
the efficacy of minocycline-based bismuth quadruple therapy for H.pylori eradication as a first-line therapy
Description
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.
Time Frame
5.5~13.5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participants was confirmed chronic atrophic gastritis by endoscopy
participants has not been previously received treatment for H.pylori infection.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue-Hua Han, PhD
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine
City
HangZhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis
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