PregnancySMARTGenHKNCT03785093
Intestinal Microbiota on Allergy, Growth and Development
An observational study of Pregnancy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2018to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Chinese families in Hong Kong
Who may be able to join
- 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
- Willing for her coming newborn to be prospectively followed up for clinical and microbiota data collection in PWH
- Participate voluntarily and capable of giving informed consent
Who cannot join
- 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
- Foetal chromosomal or clinically significant structural abnormalities
- The current pregnancy is a conception through either sperm or ovum donation
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital
Hong Kong, Hong Kong, China, Shatin
About this study
Official title: Intestinal Microbiota on Allergy, Growth and Development of the Next Generation in Hong Kong
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.
Read the detailed 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.
- Conditions
- Pregnancy
- Keywords
- Microbiota, Allergy, Growth, Development, offspring
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Family | Chinese parents and their offsprings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite allergy disease
wheezing, asthma, skin atopy, food allergy
Measured: 3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Nov 2018
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-fan Leung, Chinese University of Hong Kong
- Investigators
- Ting Fan Leung, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785093
- Sponsor's protocol ID
- Smart-002
- Acronym
- SMARTGenHK
- Status last verified
- Sep 2023
- First submitted
- 20 Dec 2018
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He Y, Zhang L, Chen Z, Chan PKS, Leung TF, Tam WH. The associations of pre-pregnancy BMI and gestational weight gain with maternal gut microbiota. Benef Microbes. 2024 Jul 3;15(4):397-410. doi: 10.1163/18762891-bja00018.
PubMed 38955351
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota on Allergy, Growth and Development of the Next Generation in Hong Kong
- ClinicalTrials.gov ID
- NCT03785093
- Acronym / sponsor ID
- SMARTGenHK / Smart-002
- Conditions
- Pregnancy
- Keywords
- Microbiota, Allergy, Growth, Development, offspring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Family | – | –Chinese parents and their offsprings |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Chinese families in Hong Kong
Key inclusion criteria (6 listed)
- 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
- Willing for her coming newborn to be prospectively followed up for clinical and microbiota data collection in PWH
Key exclusion criteria (6 listed)
- 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
- Foetal chromosomal or clinically significant structural abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite allergy disease
Time frame: 3 years of age
wheezing, asthma, skin atopy, food allergy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 38955351He Y, Zhang L, Chen Z, Chan PKS, Leung TF, Tam WH. The associations of pre-pregnancy BMI and gestational weight gain with maternal gut microbiota. Benef Microbes. 2024 Jul 3;15(4):397-410. doi: 10.1163/18762891-bja00018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Fan Leung principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite allergy disease (time frame: 3 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.