Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923113
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2021-05-30
Brief Title:
Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As we knowHelicobacter pylori is closely related to many gastrointestinal diseases such as chronic gastritis peptic ulcer diseasegastric carcinoma and gastric mucosa-associated lymphoid tissue lymphomaas well as extra-digestive diseases such as urticaria and chronic obstructive pulmonary diseases and so onThe diagnosis of H pylori infection is based on invasive methods requiring endoscopy and biopsyeg histology culture rapid urease test PCR or on non-invasive methods eg serology 13C urea breath test stool antigen testHistology has the highest specificity among the othersand also allows us to determine the underlying disease and perform antibiotic sensitivity testingSerological tests are widely available and more appropriate for epidemiological studies their main weakness for clinical use is low specificityThe 13C urea breath test is the most accurate method in patients irrespective of ageStool antigen testingas 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 specimenSensitivity and specificity usefulnessand 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 gastritisExcept thatpatients with Hp positive will be further treated with 10-day minocycline-based quadruple therapyto observe the efficacy and safety of minocycline-based regimen for Hpylori 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 study5 different methodsincluding histology13C urea breath teststool antigen testserological antibody test for Hpylori and serologic test with a current infection marker of Hpyloriwill be performed to detect H pylori infectionAnd patients with Hp positive will be further treated with 10-day minocycline-based quadruple therapyOur objective is to compare specificity and sensitivity of the current methods among patients with chronic atrophic gastritismeanwhileto observe the efficacy and safety of minocycline-based regimen for Hpylori eradication as a first-line therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None