Study Results
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Basic Information
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RECRUITING
NA
4403 participants
INTERVENTIONAL
2022-07-19
2029-04-30
Brief Summary
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Initially, we planned to recruit 10,000 adults aged ≥20 years who had not previously undergone H. pylori screening or treatment. Eligible participants were to be randomly allocated in a 1:1:1:1 ratio to one of four groups, each receiving a different combination of diagnostic tests. However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B (HpSA method) and Group D (Two-stage screening method). The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A (UBT method) and Group C (standard method) will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.
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Detailed Description
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Objective: A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of C13 UBT and HpSA in a population-based H. pylori screening and gastric cancer prevention program.
Methods：Open labeled, randomized controlled trial Initially, the investigators will recruit adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients were randomly 1:1:1:1 allocated to (A) The carbon-13 urea breath test (C13 UBT), (B) H. pylori stool antigen test (Vstrip® HpSA), (C) Standard method (Both C13 UBT and HpSA), (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive). However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B and Group D. The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A and Group C will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.
Outcome analysis:
1. Detection rate of H. pylori infection
2. To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.
3. To assess the diagnostic accuracy of these tests.
4. To verify the compliance(/adherence) and feasibility of this two-stage screening method
5. Long-term Outcomes: To assess the risk reduction of gastric cancer
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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UBT
UBT
H. pylori diagnostic test: C13 urea breath test
HpSA
HPSA
H. pylori diagnostic test: H. pylori stool antigen test
Standard method
UBT and HPSA
H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
Two-stage screening method
Serology (two stage)
H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.
Interventions
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UBT
H. pylori diagnostic test: C13 urea breath test
HPSA
H. pylori diagnostic test: H. pylori stool antigen test
UBT and HPSA
H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
Serology (two stage)
H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.
Eligibility Criteria
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Inclusion Criteria
* Never screened and treated for H. pylori infection
Exclusion Criteria
* Patients with gastric cancer
* Have been screened or tested for H. pylori infection
* Ever received H. pylori eradication therapy
* Have taken proton pump inhibitor within two weeks
* Have taken antibiotics within two weeks
20 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202203064RINC
Identifier Type: -
Identifier Source: org_study_id
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