Human Genes and Microbiota in Early Life (HuGME)

Human Genes and Microbiota in Early Life (HuGME)

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Type 2 Diabetes; Childhood Obesity; Neurodevelopmental Disorders; Immune Development; Host and Microbiome; Pregnancy Outcomes
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Xiu Qiu,, PhD; Phone Number: 0086 20 38367160; Email: qxiu0161@163.com
• Study Contact Backup: Name: Jianrong He, PhD; Phone Number: 0086 20 38367159; Email: jianrong.he@bigcs.org

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Guangzhou Women and Children's Medical Center, China
    • Contact: Xiu Qiu, MD,PhD; Phone Number: 86-020-38367160; Email: xiu.qiu@bigcs.org
    • Contact: Jian-Rong He, MD, PhD; Phone Number: 86-020-38367160; Email: jianrong.he@bigcs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurodevelopment during early childhood	Including adaptive, gross motor, fine motor,language,and social function; assessed using Gesell Developmental Schedules	at age of 3 years
Neurodevelopment during early childhood	Including adaptive, gross motor, fine motor,language,and social function; assessed using Ages and Stages Questionnaire	at age of 3 years
Neurodevelopment during preschool age	Including solving skills, pattern perception, and logical thinking；assessed using Raven's Standard Progressive Matrices	at age of 6 years
Neurodevelopment during preschool age	Including solving skills, pattern perception, and logical thinking；assessed using Peabody Picture Vocabulary Test	at age of 6 years
Neurodevelopment during preadolescence	Including higher-level cognitive processes such as attention, perseverance, WM, abstract thinking, CF, and set shifting;assessed using Raven's Standard Progressive Matrices	at age of 8-9 years
Neurodevelopment during preadolescence	Including higher-level cognitive processes such as attention, perseverance, WM, abstract thinking, CF, and set shifting;assessed using Wsiconsin card sorting test	at age of 8-9 years
maternal and childhood abnormal glucose metabolism after delivery	blood glucose level：glycosylated hemoglobin，fasting blood glucose, 1-hour glucose, 2-hour glucose, ect.	3, 6 and 9 years after delivery
maternal and childhood abnormal lipid metabolism after delivery	Lipid level : total cholesterol, triglycerides, LDL, HDL, etc.	3, 6 and 9 years after delivery

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center
• Investigators: Principal Investigator: Xiu Qiu, PhD, Study Principal Investigator Guangzhou Women and Children's Medical Center, China

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): December 31, 2038

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Overweight; Obesity; Neurodevelopmental Disorders; Pregnancy Complications; Pediatric Obesity
• Other Study ID Numbers: 201807010086; 82003471 (Other Grant/Funding Number: National natural science foundation of China); 2021A1515110194 (Other Grant/Funding Number: GuangDong Basic and Applied Basic Research Foundation); SL2024A04J0217 (Other Grant/Funding Number: Guangzhou Science and Technology Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No