Effects of gut microbiome and environment on the development of eczema in Chinese infants

ISRCTN	ISRCTN44080054
DOI	https://doi.org/10.1186/ISRCTN44080054

Submission date: 20/02/2020
Registration date: 29/02/2020
Last edited: 17/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Carmen Chan
Scientific

Room 732, Esther Lee Building
Chinese University of Hong Kong
Hong Kong
NA
Hong Kong

Phone	+852 (0)39436218
Email	whchan@cuhk.edu.hk

Study information

Study design	Prospective cohort study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Home
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a participant information sheet
Scientific title	Early-life gut microbiome and environmental factors in the development of eczema in Chinese children
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/09/2016
Completion date	31/12/2020

Eligibility

Participant type(s)	Healthy volunteer
Age group	Neonate
Sex	Both
Target number of participants	1250
Total final enrolment	215
Key inclusion criteria	1. Full-term infants 2. Chinese ethnicity 3. Resident in Hong Kong
Key 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
Date of first enrolment	29/11/2016
Date of final enrolment	31/12/2019

Locations

Countries of recruitment

Hong Kong

Study participating centres

The Nethersole School of Nursing, The Chinese University of Hong Kong

Esther Lee Building
The Chinese University of Hong Kong
Hong Kong
-
Hong Kong

Department of Paediatrics, The Chinese University of Hong Kong

Prince of Wales Hospital, Shatin
Hong Kong
-
Hong Kong

Sponsor information

Chinese University of Hong Kong
University/education

The Nethersole School of Nursing
6/F, Esther Lee Building
Shatin
Hong Kong
-
Hong Kong

Phone	+852 (0)39438174
Email	nursing@cuhk.edu.hk
Website	http://www.nur.cuhk.edu.hk/home-page/
"ROR"	https://ror.org/00t33hh48

Funders

Funder type

University/education

Chinese University of Hong Kong
Government organisation / Universities (academic only)

Alternative name(s): The Chinese University of Hong Kong, 香港中文大学, CUHK
Location: Hong Kong

Results and Publications

Intention to publish date	30/06/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in peer-reviewed journals at 6-12 months after the data collection was ended.
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article		19/01/2021	15/06/2021	Yes	No
Results article	pilot study results	20/10/2020	15/06/2021	Yes	No
Results article		01/11/2018	17/06/2021	Yes	No

Editorial Notes

17/06/2021: Publication reference and total final enrolment number added.
15/06/2021: Publication references added.
21/02/2020: Trial's existence confirmed by The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee.