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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04117321
Other study ID # MOMmy study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 23, 2019
Est. completion date October 2, 2027

Study information

Verified date May 2024
Source Chinese University of Hong Kong
Contact Jessica Ching
Phone +852 26373260
Email jessicaching@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The human intestinal tract harbors a diverse and complex microbial community, known as gut microbiota, which is critical in sustaining physiology, metabolism, nutrition and immune function. Dysbiosis of gut microbiota has been linked with obesity, hyperglycemia, hyperlipidemia, inflammatory bowel disease and other chronic inflammatory diseases. Gut microbiota is affected by host genetic markup, diet and life style; and therefore varied by human races and geographical locations. The development of gut microbiota starts before birth. The infant's microbiome can impact on human health in later life. The microbiome of pregnant women are associated with early-life microbiota of their offspring as well as growth, neurodevelopment and the development of allergic and neurocognitive disorders. Early childhood, when the microbiota is less mature and more malleable, is a golden age for microbiota manipulation to prevent disease. Studying microbiota at this golden age also allow us to dissect the development of a faulty microbiota and identify therapeutic targets to reverse it and cure diseases that are already developed.


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date October 2, 2027
Est. primary completion date October 2, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Pregnant women Inclusion Criteria: 1. Being pregnant 2. Plan to give birth in local hospital 3. Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) 4. Plan to stay in the same local area for at least 7 years post-delivery Exclusion Criteria: No New Born Baby Inclusion Criteria 1. Be a new born baby of an enrolled pregnant woman 2. One of the parents or legal guardian is competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) Exclusion Criteria: No Father of new born baby Inclusion Criteria 1. Biological father of an enrolled new born baby 2. Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) Exclusion Criteria: No

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Prince of Wales Hospital Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Develop a 100,000 pair of mother-baby longitudinal cohort Set up a large scale database to collect data such as comprehensive clinical data, such as mother's and father's demographic and clinical information (e.g. age, weight, gender, family medical history, dietary, drug usage etc.) 8 year
Secondary Dissect the important microbiome that maintain health Study samples will be collected to characterize which microbiota will be transmitted from mother to baby by performing metagenomics of gut microbiome in stool and other samples 8 year
Secondary Seize the golden period of early life for prevention of human diseases Study samples will be collected to characterize which microbiota induces disease by performing metagenomics of gut microbiome in stool and other samples and develop treatment with microbiota. 8 year
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