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Recruiting NCT04117321

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

Observational Gut Microbiome Mother to Child Transmission

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gut Microbiome, Mother to Child Transmission. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Develop a 100,000 pair of mother-baby longitudinal cohort [Time frame: 8 year]
Secondary outcome measures (2)
  • Dissect the important microbiome that maintain health [Time frame: 8 year]
  • Seize the golden period of early life for prevention of human diseases [Time frame: 8 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT04117321 · MOMmy study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗