H. Pylori Infection
Conditions
Keywords
H. pylori, screening
Brief summary
There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based H. pylori screening and gastric cancer prevention program. 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.
Detailed description
Background: There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. 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
Interventions
DIAGNOSTIC_TESTUBT
H. pylori diagnostic test: C13 urea breath test
DIAGNOSTIC_TESTHPSA
H. pylori diagnostic test: H. pylori stool antigen test
DIAGNOSTIC_TESTUBT and HPSA
H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
DIAGNOSTIC_TESTSerology (two stage)
H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 20 years or older * Never screened and treated for H. pylori infection
Exclusion criteria
* Ever undergone gastrectomy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rates of H. pylori infection | 2-8 weeks | The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups | 2 weeks to 1 year | Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection. |
Countries
Taiwan
Contacts
Primary ContactJyh-Ming Liou, MD,PhD
Outcome results
None listed