Condition category
Skin and Connective Tissue Diseases
Date applied
20/02/2020
Date assigned
29/02/2020
Last edited
28/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://www.nur.cuhk.edu.hk/home-page/

Funders

Funder type

University/education

Funder name

Chinese University of Hong Kong

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

21/02/2020: Trial's existence confirmed by The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee.