Plain English Summary
Background and study aims
Eczema is a relapsing and persistent inflammatory skin disease affecting about one-fifth of children worldwide. As in other developed countries, the prevalence of this chronic disease in Hong Kong is approximately 30%. Moreover, the number of local cases reported has been on a rising trend since 1995. Eczema frequently starts in early infancy. A total of 45% of all cases begin within the first six months of life, 60% during the first year and 85% before the age of five. The aims of this study are to characterize the changes of gut microbial profile in early childhood and to examine the association between microbiome diversity, environmental factors and the development of eczema in early childhood.
Who can participate?
Full-term newborns within 10 days from birth with Chinese ethnicity and residing in Hong Kong
What does the study involve?
Parents are asked to provide demographic data, their infant’s birth data and allergy condition by questionnaires. Stool specimens from the newborns are collected for gut microbiome diversity testing. For a better understanding of the prevalence and severity of eczema, the infants are followed for 2 years, with four follow-up measurement points to assess maternal stress, gut microbiota, diet, environment and allergy condition of the infants at the ages of 10 days, 4 months, 1 year and 2 years.
What are the possible benefits and risks of participating?
There are no possible benefits and risks of participating.
Where is the study run from?
The Chinese University of Hong Kong (Hong Kong)
When is the study starting and how long is it expected to run for?
September 2016 to December 2020
Who is funding the study?
The Chinese University of Hong Kong (Hong Kong)
Who is the main contact?
Prof. Carmen Chan
whchan@cuhk.edu.hk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Carmen Chan
ORCID ID
Contact details
Room 732
Esther Lee Building
Chinese University of Hong Kong
Hong Kong
NA
Hong Kong
+852 (0)39436218
whchan@cuhk.edu.hk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Early-life gut microbiome and environmental factors in the development of eczema in Chinese children
Acronym
Study hypothesis
1. Early-life environmental and lifestyle risk factors are associated with the development of eczema
2. There is longitudinal association of gut microbiome diversity in the development of eczema in early childhood
3. Microbiome diversity mediates the relationships between development of eczema and environmental and lifestyle factors identified
Ethics approval
Approved 26/08/2016, The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong; Tel: +852 (0)26323935; Email: crec@cuhk.edu.hk), Approval #2016.321
Study design
Prospective cohort study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Home
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Eczema
Intervention
This will be a prospective birth cohort study of 1,250 Chinese newborns in which parents will be asked to provide demographic data, their infant birth data and allergy condition by questionnaires. Stool specimens from the newborns will be collected for gut microbiome diversity testing. For a better understanding of the prevalence and severity of eczema, the cohort will be followed for two years, with three follow-up measurement points to assess the diet, environment, allergy condition and gut microbiome changes of the infants at the ages of four months, one year and two years. Parental stress will also be assessed at three timepoints. Because of the large sample size and two-year follow up, it is expected that the study will take 36 months to complete.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Gut microbiome diversity profile analysed by 16S sequencing of DNA extracted from the stool at enrolment, 4 months, 1 year and 2 years
Secondary outcome measures
Measured at enrolment, 4 months, 1 year and 2 years:
1. Infant’s allergy condition assessed by the modified parent proxy version of the Comprehensive Early Childhood Allergy Questionnaire
2. The subjects’ dietary factors assessed by a parent proxy dietary practice questionnaire, adopted from the Chinese version of the eating-habit module of the Behavioural Risk Factor Surveillance System
3. Parents’ level of stress assessed by ten-item Perceived Stress Scale
Overall trial start date
01/09/2016
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Full-term infants
2. Chinese ethnicity
3. Resident in Hong Kong
Participant type
Healthy volunteer
Age group
Neonate
Gender
Both
Target number of participants
1250
Participant exclusion criteria
1. Infants with GI disorders after birth
2. Admitted to neonatal ICU
3. Mothers have fever or an infection or are currently taking antibiotics
Recruitment start date
29/11/2016
Recruitment end date
31/12/2019
Locations
Countries of recruitment
Hong Kong
Trial participating centre
The Nethersole School of Nursing, The Chinese University of Hong Kong
Esther Lee Building
The Chinese University of Hong Kong
Hong Kong
-
Hong Kong
Trial participating centre
Department of Paediatrics, The Chinese University of Hong Kong
Prince of Wales Hospital, Shatin
Hong Kong
-
Hong Kong
Sponsor information
Organisation
Chinese University of Hong Kong
Sponsor details
The Nethersole School of Nursing
6/F
Esther Lee Building
Shatin
Hong Kong
-
Hong Kong
+852 (0)39438174
nursing@cuhk.edu.hk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Chinese University of Hong Kong
Alternative name(s)
CUHK
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Hong Kong
Results and Publications
Publication and dissemination plan
Planned publication in peer-reviewed journals at 6-12 months after the data collection was ended.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
30/06/2021
Participant level data
Other
Basic results (scientific)
Publication list