Helicobacter Pylori Eradication
Conditions
Brief summary
Although Urea breath test has been commonly used to recheck the efficiency of Helicobacter pylori eradication, there has been no randomized trials comparing the accuracy of Urea breath test results at different times after eradication. The investigators aim to assess the accuracy and influence factors of post-therapy test at different times and follow up the cut off samples to optimize the best time to recheck.
Detailed description
The investigators plan to conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after the treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.
Interventions
DIAGNOSTIC_TESTHY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times
Carbon 13 breath tests are generally performed 4-6 weeks after eradication therapy. The control group will perform breath urea test at 4-6 weeks after treatment. The experimental groups will perform the same test at different times after the same treatment, 6-8weeks and 8-10 weeks, respectively.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The investigators will conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* no history of helicobacter pylori treatment * the diagnosis of H. pylori infection was confirmed by one or more of the following methodologies before treatment: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), and/or the 13C-UBT.
Exclusion criteria
* used antibiotics or bismuth within four weeks before inclusion or acid inhibitor use, including H2 receptor antagonist (H2RA), PPI or P-CAB use, within two weeks prior to inclusion. * had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction. * had a history of esophagectomy or gastrectomy. * had an allergy to any study drug. * had severe comorbidities or physical or mental diseases. * were pregnant or breastfeeding. * had a history of alcohol abuse or drug addiction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the eradication rate in each group (ITT analysis) | up to 4 months after eradication therapy | According to the breath urea test, calculation the eradication rate in the three groups. ITT analysis, the number of negative breath test cases after treatment divided by the number of cases enrolled in eradication therapy. |
| the eradication rate in each group (PP analysis) | up to 4 months after eradication therapy | According to the breath urea test, calculation the eradication rate in the three groups. PP analysis, the number of negative breath test cases after treatment divided by the number of cases finished the eradication therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| follow up of cut off cases | up to 4 months after eradication therapy. | If the result of breath urea test is betwwen 2 to 6, it will be defined as cut off value. These cases will be collected and take further tests to make sure the real situation of helicobacter pylori infection. |
Countries
China
Contacts
Primary ContactYuehua Han, MD
Outcome results
None listed