Comparison of Different Helicobacter Pylori Detection Methods in Patients With Chronic Atrophic Gastritis

NCT04923113 | Completed

• 1 other identifier: 2021-0290
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 2

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (1)

• the efficacy of minocycline-based bismuth quadruple therapy for H.pylori eradication as a first-line therapy

  5.5~13.5 weeks

Study Arms (1)

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.

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

Interventions

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 DIAGNOSTIC_TEST

The above 5 detection methods will be performed in patients who meet the inclusion criteria to detect H. pylori infection

patients who meet the inclusion criteria

Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectin DRUG

Helicobacter pylori positive patients will be treated with rabeprazole10mg,minocycline 100mg,amoxicillin1000mg,and colloidal bismuth pectin 200mg,all twice daily for 10 days

patients who meet the inclusion criteria

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants was confirmed chronic atrophic gastritis by endoscopy
• participants has not been previously received treatment for H.pylori infection.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (2)

Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Serologic Tests

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Yue-Hua Han, PhD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 11, 2021
• Study Start: June 28, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 18, 2023
• Last Updated: February 24, 2023

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)