Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Intrafamilial Helicobacter Pylori Infection in Hong Kong
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Prevalence and Risk Factors of Intrafamilial Helicobacter Pylori Infection in Hong Kong a Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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 5027 to 8506 In another study in central China it was found that all family members were infected with H pylori in 278 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 43 95CI 4-5 31 95CI 2-5 and 22 95CI 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 71 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 386 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
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 5027 to 8506 In another study in central China it was found that all family members were infected with H pylori in 278 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 43 95CI 4-5 31 95CI 2-5 and 22 95CI 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 71 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 386 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None