NCT05870397

Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective Randomized Trial

Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective, Single-center, Open-label, Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Pylori Eradication

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HY-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.

Timeline

• Start date: 2023-04-21
• Primary completion: 2024-04-21
• Completion: 2024-08-21
• First posted: 2023-05-23
• Last updated: 2023-05-23

Locations

1 site across 1 country: China