Mother-infant Microbiota Transmission and Its Link to the Health of the Baby

Recruiting

• Conditions: Mother to Child Transmission; Gut Microbiome

• Registration Number: NCT04117321
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-23
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-26
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-10-02
• Study Completion: 2027-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop a 100,000 pair of mother-baby longitudinal cohort	8 year	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.)

Secondary Outcome Measures

Name	Time	Method
Seize the golden period of early life for prevention of human diseases	8 year	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.
Dissect the important microbiome that maintain health	8 year	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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, Hong Kong, China