Human Genes and Microbiota in Early Life

Official title

Human Genes and Microbiota in Early Life (HuGME)

Overview

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.

Interventions

• Other No intervention
  No intervention

Primary outcome measures

• Numbers of participants with Childhood diseases. Including: [Time frame: 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years of age]
• Numbers of participants with maternal diseases. Including: [Time frame: during pregnancy, 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years after delivery]

Secondary outcome measures (8)

• Neurodevelopment during early childhood [Time frame: at age of 3 years]
• Neurodevelopment during early childhood [Time frame: at age of 3 years]
• Neurodevelopment during preschool age [Time frame: at age of 6 years]
• Neurodevelopment during preschool age [Time frame: at age of 6 years]
• Neurodevelopment during preadolescence [Time frame: at age of 8-9 years]
• Neurodevelopment during preadolescence [Time frame: at age of 8-9 years]
• maternal and childhood abnormal glucose metabolism after delivery [Time frame: 3, 6 and 9 years after delivery]
• maternal and childhood abnormal lipid metabolism after delivery [Time frame: 3, 6 and 9 years after delivery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

• Guangzhou Women and Children's Medical Center, China — Guangzhou

Publications

• 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 28321694
• 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. PMID 28873967
• 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. PMID 37929652
• 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. PMID 27827448
• 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. PMID 27226242

Identifiers

NCT: NCT06926166 · 201807010086 · 82003471 · 2021A1515110194 · SL2024A04J0217

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗