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

NCT ID: NCT05870397

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2024-08-21

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.

Conditions

Helicobacter Pylori Eradication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Recheck time is at 4 to 6 weeks after the eradication therapy

All cases are administered 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 4 to 6 weeks( as guildeline suggested) after the treatment.

Group Type: PLACEBO_COMPARATOR

HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times

Intervention Type: DIAGNOSTIC_TEST

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.

Recheck time is at 6 to 8 weeks after eradication therapy

All cases are administered 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 6 to8 weeks after the treatment.

Group Type: ACTIVE_COMPARATOR

HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times

Intervention Type: DIAGNOSTIC_TEST

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.

Recheck time is at 8 to 10 weeks after eradication therapy

All cases are administered 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 8 to 10 weeks after the treatment.

Group Type: ACTIVE_COMPARATOR

HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianting Cai, MD

Role: STUDY_CHAIR

2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China

Locations

2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuehua Han, MD

Role: CONTACT

13858126927@163.com

+86057189713734

Facility Contacts

Yuehua Han, MD

Role: primary

13858126927@163.com

+8613858126927

Other Identifiers

2023-0184

Identifier Type: -

Identifier Source: org_study_id