Human Genes and Microbiota in Early Life
HuGME
4 other identifiers
observational
20,000
1 country
1
Brief Summary
The long-term goal of the Human Genes and Microbiota in Early Life (HuGME) is to explore the short- and long-term effects of maternal microbiota during pregnancy and the microbiota colonization of their offspring early in life and their interaction with the host on maternal-offspring health consequences in later life in the born in Guangzhou cohort study in China. Identification of the effect of microbiota in early life, as well as environmental factors and microbe-host interaction, will lead to a better understanding of disease pathogenesis and provide a foundation for targeted mechanistic investigation into the consequences of microbial-host crosstalk for long-term health. It also can result in new strategies to predict and prevent diseases in later life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Longer than P75 for all trials
1 active site
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
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 26, 2025
CompletedFirst Posted
Study publicly available on registry
April 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2038
April 13, 2025
April 1, 2025
19.8 years
March 26, 2025
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Numbers of participants with Childhood diseases. Including:
Obesity，asthma，allergic diseases，Delayed neural development，type 1 diabetes，maturity-onset diabetes of the young（MODY), hypertension
42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years of age
Numbers of participants with maternal diseases. Including:
Obesity，asthma，allergic diseases，type 1 diabetes，type 2 diabetes, hypertension , cardiovascular diseases，and obstetric complications，including gestational diabetes，pregnancy induced hypertension, ect.
during pregnancy, 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years after delivery
Secondary Outcomes (8)
Neurodevelopment during early childhood
at age of 3 years
Neurodevelopment during early childhood
at age of 3 years
Neurodevelopment during preschool age
at age of 6 years
Neurodevelopment during preschool age
at age of 6 years
Neurodevelopment during preadolescence
at age of 8-9 years
- +3 more secondary outcomes
Study Arms (1)
No treatment
No treatment
Interventions
Eligibility Criteria
Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping
You may qualify if:
- Pregnant women with \< 20 weeks of gestation Pregnant women intended to eventually deliver in Guangzhou Women and Children's medical center Permanent residengts of families intended to remain in Guangzhou with their child for ≥3 years
You may not qualify if:
- Refuses to have blood and stool samples stored at Born in Guangzhou cohort study Biobank.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Women and Children's Medical Center, China
Guangzhou, China
Related Publications (5)
Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.
PMID: 28321694BACKGROUNDKuang YS, Lu JH, Li SH, Li JH, Yuan MY, He JR, Chen NN, Xiao WQ, Shen SY, Qiu L, Wu YF, Hu CY, Wu YY, Li WD, Chen QZ, Deng HW, Papasian CJ, Xia HM, Qiu X. Connections between the human gut microbiome and gestational diabetes mellitus. Gigascience. 2017 Aug 1;6(8):1-12. doi: 10.1093/gigascience/gix058.
PMID: 28873967BACKGROUNDGao C, Shao DT, Wang CR, Kuang YS, Lu JH, Zeng DY, He JR, Qiu X. Long-term effect of caesarean section on the gut microbial taxonomical profile and metabolic function of children at pre-school age. Clin Transl Med. 2023 Nov;13(11):e1470. doi: 10.1002/ctm2.1470. No abstract available.
PMID: 37929652BACKGROUNDKuang YS, Li SH, Guo Y, Lu JH, He JR, Luo BJ, Jiang FJ, Shen H, Papasian CJ, Pang H, Xia HM, Deng HW, Qiu X. Composition of gut microbiota in infants in China and global comparison. Sci Rep. 2016 Nov 9;6:36666. doi: 10.1038/srep36666.
PMID: 27827448BACKGROUNDGuo Y, Li SH, Kuang YS, He JR, Lu JH, Luo BJ, Jiang FJ, Liu YZ, Papasian CJ, Xia HM, Deng HW, Qiu X. Effect of short-term room temperature storage on the microbial community in infant fecal samples. Sci Rep. 2016 May 26;6:26648. doi: 10.1038/srep26648.
PMID: 27226242BACKGROUND
Biospecimen
During pregnancy: maternal blood, urine, and stool. At delivery: cord, cord blood, and placenta. During infancy: dry blood spots, stool, and blood. During childhood: blood, buccal swab, and stool.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiu Qiu, PhD
Study Principal Investigator Guangzhou Women and Children's Medical Center, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The division of the born in Guangzhou cohort study
Study Record Dates
First Submitted
March 26, 2025
First Posted
April 13, 2025
Study Start
April 1, 2019
Primary Completion (Estimated)
December 31, 2038
Study Completion (Estimated)
December 31, 2038
Last Updated
April 13, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share