Clinical trial NCT06926166: Human Genes and Microbiota in Early Life
Official title: Human Genes and Microbiota in Early Life (HuGME)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Host and Microbiome
Pregnancy Outcomes
Pregnancy Complications
Neurodevelopmental Disorders
Immune Development
Childhood Obesity
Type 2 Diabetes
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping

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.

Detailed description: Prenatal and early postnatal life represent critical windows for growth and cognitive and immune system development. In addition to genetics and host biology, the environment plays a critical role in the health of a child. One key player in this process is the maternal and infant gut microbiomes. The establishment and progression of the intestinal microbiota from birth to childhood are dependent on a range of factors, including maternal microbiota, diet, environment, and medical exposures. The host-microbial crosstalk during this time is thought to be involved in the pathobiology of later-life diseases, such as allergic disease, obesity, and neurodevelopmental delay. Although the microbiome and its importance for health have been extensively studied, it remains unclear how maternal microbiota-fetal interaction, the establishment, and progression of microbiota in infant adaptation to postnatal environmental exposures, and microbial-host crosstalk affect the health of the children in later life.

Hypotheses:

1. Maternal microbiota-fetal interaction has an essential effect on fetal immune system development and adverse pregnancy outcomes.
2. Host genes can shape infant gut microbial assembly and metabolism.
3. Early-life interactions between host genes and microbiota have an impact on immune system development and atopic disease in later life.
4. Co-metabolism of the gut microbiome and metabolites in the host affects childhood obesity
5. Early-life interactions between the host and microbiota have an impact on the neurodevelopment of the children.
6. Maternal microbiota influence the metabolism of the mother during pregnancy and postpartum.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Refuses to have blood and stool samples stored at Born in Guangzhou cohort study Biobank.

Primary outcomes:
measure: Numbers of participants with Childhood diseases. Including:
timeFrame: 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years of age
measure: Numbers of participants with maternal diseases. Including:
timeFrame: during pregnancy, 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years after delivery
Secondary outcomes:
measure: Neurodevelopment during early childhood
timeFrame: at age of 3 years
measure: Neurodevelopment during early childhood
timeFrame: at age of 3 years
measure: Neurodevelopment during preschool age
timeFrame: at age of 6 years
measure: Neurodevelopment during preschool age
timeFrame: at age of 6 years
measure: Neurodevelopment during preadolescence
timeFrame: at age of 8-9 years
measure: Neurodevelopment during preadolescence
timeFrame: at age of 8-9 years
measure: maternal and childhood abnormal glucose metabolism after delivery
timeFrame: 3, 6 and 9 years after delivery
measure: maternal and childhood abnormal lipid metabolism after delivery
timeFrame: 3, 6 and 9 years after delivery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center, China
Study officials:
affiliation: Study Principal Investigator Guangzhou Women and Children's Medical Center, China
name: Xiu Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kuang 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.
citation: Gao 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.
citation: Kuang 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.
citation: Guo 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.