Clinical trial NCT04117321: Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
Official title: Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gut Microbiome
Mother to Child Transmission
Keywords: Mommy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Develop a 100,000 pair of mother-baby longitudinal cohort
timeFrame: 8 year
Secondary outcomes:
measure: Dissect the important microbiome that maintain health
timeFrame: 8 year
measure: Seize the golden period of early life for prevention of human diseases
timeFrame: 8 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
state: Hong Kong
Study officials:
References: