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

Zhejiang University

Status: Enrolling

Conditions: Helicobacter Pylori Eradication

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05870397

2023-0184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

900 participants in 3 patient groups, including a placebo group

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

Placebo Comparator group

Description:

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.

Treatment:

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

Recheck time is at 6 to 8 weeks after eradication therapy

Active Comparator group

Description:

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.

Treatment:

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

Recheck time is at 8 to 10 weeks after eradication therapy

Active Comparator group

Description:

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.

Treatment:

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