Suspended

SMARTGenHKIntestinal Microbiota on Allergy, Growth and Development of the Next Generation in Hong Kong

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Hypersensitivity

+ Immune System Diseases

From 18 to 45 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Family-Based

Studying health outcomes within families in order to identify genetic or familial contributions to disease.
Observational
Study Start: November 2018
See protocol details

Summary

Principal SponsorChinese University of Hong Kong
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleIntestinal Microbiota on Allergy, Growth and Development of the Next Generation in Hong Kong
NCT03785093
Principal SponsorChinese University of Hong Kong
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Family-Based

These studies involve members of the same family to explore how genetics and shared environments may contribute to a disease. They help researchers pinpoint inherited risk factors.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypersensitivityImmune System Diseases

Criteria

6 inclusion criteria required to participate
Expectant ethnic Chinese mothers aged 18 - 45 years who are in the first trimester of pregnancy

Singleton pregnancy

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

Willing to provide serial biological samples for microbiota detection

Show More Criteria

6 exclusion criteria prevent from participating
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

History of chronic inflammatory or neoplastic diseases involving the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, colorectal cancer)

Significant pregnancy complications, such as intrauterine foetal demise/stillbirth, extreme prematurity, or pre-labour rupture of membranes before 24 weeks

Mother with mental incapacity such that they are not able to give informed consent

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Prince of Wales Hospital

Hong Kong, Hong KongOpen Prince of Wales Hospital in Google Maps
SuspendedOne Study Center
SMARTGenHK | Intestinal Microbiota on Allergy, Growth and Development of the Next Generation in Hong Kong | PatLynk