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

Gut Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117321
• Other study ID #: MOMmy study
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Gut Microbiome
• Mother to Child Transmission

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