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NCT Number: NCT04117321

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

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.

Recruiting

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Key information

Conditions

Gut Microbiome Mother to Child Transmission

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong, China

Location status: Recruiting

Location contact

Francis KL Chan, MD

CONTACT

85226323143

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Pregnant women

Inclusion criteria

  • 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 Exclusion Criteria: No

New Born Baby Inclusion Criteria

  • 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

Father of new born baby Inclusion Criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Develop a 100,000 pair of mother-baby longitudinal cohort

    Time frame: 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 outcomes

  1. Dissect the important microbiome that maintain health

    Time frame: 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

  2. Seize the golden period of early life for prevention of human diseases

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Ching

CONTACT

[email protected]

+852 26373260

Kitty Cheung

CONTACT

[email protected]

+852 26373260

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Oct 7, 2019
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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