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

Last updated: May 22, 2023
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Helicobacter Pylori

Treatment

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

Clinical Study ID

NCT05870397
2023-0184
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • no history of helicobacter pylori treatment
  • the diagnosis of H. pylori infection was confirmed by one or more of the followingmethodologies before treatment: gastric biopsy using histochemical staining, tissueculture, the 14C-urea breath test (UBT), and/or the 13C-UBT.

Exclusion

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 toinclusion.
  • had an active peptic ulcer with complications such as hemorrhage, perforation, orobstruction.
  • 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.

Study Design

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times
Phase:
Study Start date:
April 21, 2023
Estimated Completion Date:
August 21, 2024

Study 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.

Connect with a study center

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

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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