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.

Study Overview

• Status: Recruiting
• Conditions: Gut Microbiome; Mother to Child Transmission

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Jessica Ching; Phone Number: +852 26373260; Email: jessicaching@cuhk.edu.hk
• Study Contact Backup: Name: Kitty Cheung; Phone Number: +852 26373260; Email: kittyccy@cuhk.edu.hk

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Francis KL Chan, MD; Phone Number: 85226323143

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Pregnant women; Women who are being pregnant and plan to give birth in local hospital. Pregnant women who plan to stay in the same local area for at least 7 years post-delivery.
New Born Baby; new born baby of an enrolled pregnant woman.
Father of new born baby; Biological father of an enrolled new born baby.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): October 2, 2027

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 26, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Mommy
• Other Study ID Numbers: MOMmy study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No