Intestinal Microbiota on Allergy, Growth & Development

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Our unit is one of the centres contributing to the International multicentre HAPO study. We recruited 1760 Chinese pregnant women between 2000 and 2005. The HAPO study investigated whether any adverse outcome was associated with mild degree of GDM. All mothers underwent a 75-gram OGTT at 24-32 weeks gestation, but clinicians were blinded to the results as long as the fasting PG was ≤ 5.8 mmol/L & 2-hour PG ≤ 11.1 mmol/L. The maternal serum C-peptide and HbA1c, cord serum C-peptide and early neonatal PG, pregnancy outcome and the neonatal anthropometric parameters are available for future study. This is so far the largest cohort in a Chinese population who has been investigated for glycaemia during pregnancy, but with OGTT results remained undisclosed to subjects and clinicians. This unique cohort can allow us to study the effect of in-utero hyperglycemia on the cardiometabolic risks at childhood, adolescence and adulthood. Eligible subjects are all mother-child pairs participating in the original HAPO study. Children born preterm before 37 weeks of gestation, non-Chinese and whose mother's OGTT result were unblinded during pregnancy will be excluded.The family (the child and the mother) will be invited for a third follow-up assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03785093
Study type	Observational
Source	Chinese University of Hong Kong
Contact
Status	Active, not recruiting
Phase
Start date	November 1, 2018
Completion date	June 30, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intestinal Microbiota on Allergy, Growth and Development — SMARTGenHK

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms