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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117321
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong

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.


Condition or disease
Gut Microbiome Mother to Child Transmission

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : October 2, 2026
Estimated Study Completion Date : October 2, 2027

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117321


Contacts
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Contact: Jessica Ching +852 26373260 jessicaching@cuhk.edu.hk
Contact: Kitty Cheung +852 26373260 kittyccy@cuhk.edu.hk

Locations
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China, Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, China
Contact: Francis KL Chan, MD    85226323143      
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04117321    
Other Study ID Numbers: MOMmy study
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francis KL Chan, Chinese University of Hong Kong:
Mommy