Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06425393 |
| Other study ID # |
2024.143 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 11, 2024 |
| Est. completion date |
December 10, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Chinese University of Hong Kong |
| Contact |
Felix Sia |
| Phone |
26370428 |
| Email |
felixsia[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Helicobacter pylori infects around half of the population in the world, and it is believed to
affect more than half of population in Hong Kong. H. pylori infection is a well-known cause
of chronic gastritis, peptic ulcer diseases and gastric cancer. Early detection and
eradication of H. pylori infection is of utmost importance.
H. pylori infection is mainly transmitted by oral-oral, faecal-oral routes and water sources
. Emerging studies demonstrated that intrafamilial spread is common. Recent national,
family-based epidemiological study on H. pylori infection in mainland China showed a high
familial infection rate ranging from 50.27% to 85.06%. In another study in central China, it
was found that all family members were infected with H. pylori in 27.8% of the H. pylori
infected households. Therefore, detection and eradication of H. pylori infection in family
are very important to prevent development of H. pylori related diseases. Instead of the
traditional strategies for individual-based management of H. pylori infection like 'test and
treat' and 'screen and treat' strategies, a new strategy 'family- based H. pylori infection
control and management' has been introduced. In 2021, China published a consensus report on
the Family-based H. pylori infection control and management with an aim to reduce
intrafamilial H. pylori spread in the Chinese population. In Taiwan, where the incidence of
GC is high, a preventive strategy with 13C-urea breath test screening using the index case
method and outreach the family members of the positive index cases. Eradication therapies for
those who test positive and to follow up 2 years later to test the reinfection rate has been
implemented to reduce the incidence of gastric cancers and reduce the cancer health
inequality in indigenous communities.
Previous studies have identified several risk factors for intrafamilial transmission of H.
pylori infection. Large family size of 3 or more in a household and living in highly infected
areas in Northwest China were risk factors for household H. pylori infection while family
members with higher income and education level , using serving spoons or chopsticks ,
drinking boiled water from tap source were associated with lower risk of household infection.
There is concern on the re-infection rate of H. pylori after eradication therapy. A systemic
review revealed that global annual recurrence, reinfection and recrudescence rates of H.
pylori were 4.3% (95%CI: 4-5), 3.1% (95%CI: 2-5) and 2.2% (95%CI: 1-3), respectively. An
observational study in Turkey found that for H. pylori infected patients with whole family
testing and eradication, the recurrence rate was 7.1% 9 months after treatment. On the other
hand, when only the infected patient was eradicated but the whole family infection was not
treated, the recurrence rate was 38.6% 9 months after treatment. These results suggest that
treatment of the whole infected family is of great value in controlling H. pylori
re-infection and preventing recurrence.
