Clinical trial NCT05870397: Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective Randomized Trial
Official title: Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective, Single-center, Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Eradication
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: the eradication rate in each group (ITT analysis)
timeFrame: up to 4 months after eradication therapy
measure: the eradication rate in each group (PP analysis)
timeFrame: up to 4 months after eradication therapy
Secondary outcomes:
measure: follow up of cut off cases
timeFrame: up to 4 months after eradication therapy.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China
state: Zhejiang
Study officials:
affiliation: 2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China
name: Jianting Cai, MD
role: STUDY_CHAIR
References: