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Human Genes and Microbiota in Early Life

Human Genes and Microbiota in Early Life (HuGME)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06926166
Acronym
HuGME
Enrollment
20000
Registered
2025-04-13
Start date
2019-04-01
Completion date
2038-12-31
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Host and Microbiome, Immune Development, Neurodevelopmental Disorders, Pregnancy Complications, Pregnancy Outcomes, Type 2 Diabetes

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Numbers of participants with Childhood diseases. Including:42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years of ageObesity,asthma,allergic diseases,Delayed neural development,type 1 diabetes,maturity-onset diabetes of the young(MODY), hypertension
Numbers of participants with maternal diseases. Including:during pregnancy, 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years after deliveryObesity,asthma,allergic diseases,type 1 diabetes,type 2 diabetes, hypertension , cardiovascular diseases,and obstetric complications,including gestational diabetes,pregnancy induced hypertension, ect.

Secondary

MeasureTime frameDescription
Neurodevelopment during early childhoodat age of 3 yearsIncluding adaptive, gross motor, fine motor,language,and social function; assessed using Gesell Developmental Schedules
Neurodevelopment during preschool ageat age of 6 yearsIncluding solving skills, pattern perception, and logical thinking;assessed using Raven's Standard Progressive Matrices
Neurodevelopment during preadolescenceat age of 8-9 yearsIncluding higher-level cognitive processes such as attention, perseverance, WM, abstract thinking, CF, and set shifting;assessed using Raven's Standard Progressive Matrices
maternal and childhood abnormal glucose metabolism after delivery3, 6 and 9 years after deliveryblood glucose level:glycosylated hemoglobin,fasting blood glucose, 1-hour glucose, 2-hour glucose, ect.
maternal and childhood abnormal lipid metabolism after delivery3, 6 and 9 years after deliveryLipid level : total cholesterol, triglycerides, LDL, HDL, etc.

Countries

China

Contacts

CONTACTXiu Qiu,, PhD
qxiu0161@163.com0086 20 38367160
CONTACTJianrong He, PhD
jianrong.he@bigcs.org0086 20 38367159
PRINCIPAL_INVESTIGATORXiu Qiu, PhD

Study Principal Investigator Guangzhou Women and Children's Medical Center, China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026