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Intestinal Microbiota on Allergy, Growth and Development (SMARTGenHK)

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: NCT03785093
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Wing Hung Tam, Chinese University of Hong Kong

Study Description
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Brief Summary:
There is growing evidence that microbial programming beginning in-utero can be a central component for a balanced development of innate immunity and optimal growth and development in newborns. However, the specific types of bacteria along with their cross-talk with maternal and fetal host factors are far from being clear. The investigators hypothesize microbial compositions at different body sites 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. This is a prospective birth cohort study involving Chinese mother-child pairs. The investigators will follow up 120 pregnant women from first trimester until childbirth, and the child until three years of age.

Condition or disease
Pregnancy

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Intestinal Microbiota on Allergy, Growth and Development of the Next Generation in Hong Kong
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Groups and Cohorts
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Group/Cohort
Chinese Family
Chinese parents and their offsprings


Outcome Measures
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Primary Outcome Measures :
  1. Composite allergy disease [ Time Frame: 3 years of age ]
    wheezing, asthma, skin atopy, food allergy


Biospecimen Retention:   Samples With DNA
i) Blood, urine and stool samples ii) Skin, nasal and buccal swabs iii) Maternal vaginal swabs and placental tissue biopsy iv) Breast milk

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women who are in the first trimester of pregnancy
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Chinese families in Hong Kong
Criteria

Inclusion Criteria:

  1. Expectant ethnic Chinese mothers aged 18 - 45 years who are in the first trimester of pregnancy
  2. Singleton pregnancy
  3. Plan to give birth in the Prince of Wales Hospital, Hong Kong and stay with the child in Hong Kong for the next 3 years
  4. Willing to provide serial biological samples for microbiota detection
  5. Willing for her coming newborn to be prospectively followed up for clinical and microbiota data collection in PWH
  6. Participate voluntarily and capable of giving informed consent

Exclusion Criteria:

  1. Significant medical conditions especially those required long term medications, such as oral steroid, antihypertensive drugs, diabetic medications and lipid-lowering agents, during or before pregnancy
  2. History of chronic inflammatory or neoplastic diseases involving the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, colorectal cancer)
  3. Significant pregnancy complications, such as intrauterine foetal demise/stillbirth, extreme prematurity, or pre-labour rupture of membranes before 24 weeks
  4. Mother with mental incapacity such that they are not able to give informed consent
  5. Foetal chromosomal or clinically significant structural abnormalities
  6. The current pregnancy is a conception through either sperm or ovum donation
Contacts and Locations
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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): NCT03785093


Contacts
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Contact: Wing-hung Tam 852-35052802 tamwh@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, China, Hong Kong, Shatin
Contact: Wing-hung Tam       tamwh@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Wing-hung Tam Chinese University of Hong Kong
More Information
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Responsible Party: Wing Hung Tam, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03785093    
Other Study ID Numbers: Smart-002
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Wing Hung Tam, Chinese University of Hong Kong:
Microbiota, Allergy, Growth, Development, offspring
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases