Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being pregnant
Plan to give birth in local hospital
Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent)
Plan to stay in the same local area for at least 7 years post-delivery
Disqualifiers
Be a new born baby of an enrolled pregnant woman
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
Biological father of an enrolled new born baby
Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) Exclusion Criteria: No
Trial population
This project will consist of a total 100,000 mother-baby pairs from all centers in 7 years. The study is exploratory in nature. In considering the number of events required for reliable quantification of different factors on a range of diseases, we decided to include 100,000 mother-baby pairs.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20,000 Participants
are grouped into 3 trial groupsGroup A: Pregnant women
Group B: New Born Baby
Group C: Father of new born baby
Trial outcomes
Primary outcomes
1
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.)
Time frame
8 yearSecondary outcomes
1
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
Time frame
8 year2
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.
Time frame
8 yearSponsors and contacts
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Source ClinicalTrials.gov