Intrafamilial Helicobacter Pylori Infection in Hong Kong
ConditionH.Pylori Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
It is a single-centre, prospective cohort study, which will be conducted in a tertiary academic hospital. The study aims to investigate intrafamilial H. pylori infection status and to identify risk factors for H. pylori infection among household members.
The rate of intrafamilial H. pylori spread in Hong Kong is currently unknown. It is also not clear whether the same risk factors for intrafamilial spread of H. pylori infection also apply in Hong Kong. In contrast to mainland China and Taiwan , recent consensus guideline on H. pylori management in Hong Kong in 2023 recommends against routine testing of asymptomatic household members or family members of H. pylori-infected adults. There is a knowledge gap on whether the family-based H. pylori screening is cost effective in our locality. Thus, the investigator aim to investigate infection status of household members of H. pylori infected individuals and risk factors for household infection in Hong Kong. The result from this study will shed light on the role of family-based screening and can inform future healthcare policy making on the strategy of H. pylori management and treatment in Hong Kong, ameliorating H. pylori infection-related disease and gastric cancer burden for society.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults age>=18 years of age
For H. pylori infected patients only: Diagnosed to have H. pylori infection by either histology, rapid urease test or urea breath test
Written informed consent obtained
Disqualifiers
Unable to perform urea breath test
Contraindications for urea breath test
Used antibiotics within the past month/proton pump inhibitors within two weeks
Trial design
Design model
Parallel
Treatments tested in this trial
Urea beath test (UBT)
Diagnostic testH. pylori infection will be tested using a 13C-urea breath test Kit for all enrolled family members, following the manufacturer's instructions. The sensitivity and specificity of the assay are both over 95%, according to the manufacturer's introduction.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: H. pylori positive subjectsNo intervention 0 interventions
Group B: H. pylori positive subjects' household membersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of H. pylori infection in household members
The rate of H. pylori infection in household members of H. pylori infected subjects from the given UBT
Time frame
during the study period, 2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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