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

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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

Tracking Information
First Submitted Date October 3, 2019
First Posted Date October 7, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date September 23, 2019
Estimated Primary Completion Date October 2, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 3, 2019)
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.)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 3, 2019)
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
Official Title Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, stool, saliva, hair, nail, nasopharyngeal swab, skin swab, buccal swab, placenta, cord blood, low Vaginal swab and breast milk samples
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.
Condition
  • Gut Microbiome
  • Mother to Child Transmission
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 3, 2019)
20000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2, 2027
Estimated Primary Completion Date October 2, 2026   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Jessica Ching +852 26373260 jessicaching@cuhk.edu.hk
Contact: Kitty Cheung +852 26373260 kittyccy@cuhk.edu.hk
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04117321
Other Study ID Numbers MOMmy study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Francis KL Chan, Chinese University of Hong Kong
Study Sponsor Chinese University of Hong Kong
Collaborators Not Provided
Investigators Not Provided
PRS Account Chinese University of Hong Kong
Verification Date October 2019