NCT03785093

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

6.7 years

First QC Date

December 20, 2018

Last Update Submit

September 1, 2023

Conditions

Pregnancy

Keywords

Microbiota, Allergy, Growth, Development, offspring

Outcome Measures

Primary Outcomes (1)

  • Composite allergy disease

    wheezing, asthma, skin atopy, food allergy

    3 years of age

Study Arms (1)

Chinese Family

Chinese parents and their offsprings

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who are in the first trimester of pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Chinese families in Hong Kong

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China, Shatin, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 38955351DERIVED

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

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Ting Fan Leung

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 24, 2018

Study Start

November 1, 2018

Primary Completion

June 30, 2025

Study Completion

June 30, 2026

Last Updated

September 5, 2023

Record last verified: 2023-09

Locations

HK(1)