Intrafamilial Helicobacter Pylori Infection in Hong Kong

NCT06425393 | Not Yet Recruiting

• 1 other identifier: 2024.143
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

H.Pylori Infection

Keywords

H.pylori infection

Outcome Measures

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

  during the study period, 2 years

Study Arms (2)

H. pylori positive subjects

NO INTERVENTION

The H. pylori infected subject is responsible for providing details of the number of household members, family structure, family history of gastric diseases, family economy, living conditions, family hygiene and living habits. Patients also need to provide personal information including HKID, ethnicity.

H. pylori positive subjects' household members

EXPERIMENTAL

The household members of the index subjects will be invited to complete a questionnaire which includes the baseline demographics, past medical history, personal hygiene and living habits. Also, they will be received urea beath test (UBT). Referral will be given to those positive result household members.

Diagnostic Test: Urea beath test (UBT)

Interventions

Urea beath test (UBT) DIAGNOSTIC_TEST

H. 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.

H. pylori positive subjects' household members

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to perform urea breath test
• Contraindications for urea breath test
• Used antibiotics within the past month/proton pump inhibitors within two weeks

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Central Study Contacts

Felix Sia

CONTACT

26370428; felixsia@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Model Details: Patients who are diagnosed to have H. pylori infection by either histology, rapid urease test or urea breath test will be recruited. At least 1 household member of each H. pylori infected subject will also be recruited.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: June 11, 2024
• Primary Completion: June 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share