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

NCT04117321 | Recruiting DMC

• 1 other identifier: MOMmy study
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome; Mother to Child Transmission

Keywords

Mommy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dissect the important microbiome that maintain health

  8 year

• Seize the golden period of early life for prevention of human diseases

  8 year

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Be a new born baby of an enrolled pregnant woman
• Biological father of an enrolled new born baby

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool, saliva, hair, nail, nasopharyngeal swab, skin swab, buccal swab, placenta, cord blood, low Vaginal swab and breast milk samples

Central Study Contacts

Jessica Ching

CONTACT

+852 26373260; jessicaching@cuhk.edu.hk

Kitty Cheung

CONTACT

+852 26373260; kittyccy@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: September 23, 2019
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): October 2, 2027
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

CN (1)