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NCT Number: NCT06926166

Human Genes and Microbiota in Early Life

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.

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Key information

Conditions

Host and Microbiome Body Weight Childhood Obesity Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune Development Mental Disorders Metabolic Diseases Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Pregnancy Complications Pregnancy Outcomes Signs and Symptoms Type 2 Diabetes Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Numbers of participants with Childhood diseases. Including:

    Time frame: 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years of age

    Obesity，asthma，allergic diseases，Delayed neural development，type 1 diabetes，maturity-onset diabetes of the young（MODY), hypertension

  2. 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

    Obesity，asthma，allergic diseases，type 1 diabetes，type 2 diabetes, hypertension , cardiovascular diseases，and obstetric complications，including gestational diabetes，pregnancy induced hypertension, ect.

Secondary outcomes

  1. Neurodevelopment during early childhood

    Time frame: at age of 3 years

    Including adaptive, gross motor, fine motor,language,and social function; assessed using Gesell Developmental Schedules

  2. Neurodevelopment during early childhood

    Time frame: at age of 3 years

    Including adaptive, gross motor, fine motor,language,and social function; assessed using Ages and Stages Questionnaire

  3. Neurodevelopment during preschool age

    Time frame: at age of 6 years

    Including solving skills, pattern perception, and logical thinking；assessed using Raven's Standard Progressive Matrices

  4. Neurodevelopment during preschool age

    Time frame: at age of 6 years

    Including solving skills, pattern perception, and logical thinking；assessed using Peabody Picture Vocabulary Test

  5. Neurodevelopment during preadolescence

    Time frame: at age of 8-9 years

    Including higher-level cognitive processes such as attention, perseverance, WM, abstract thinking, CF, and set shifting;assessed using Raven's Standard Progressive Matrices

  6. Neurodevelopment during preadolescence

    Time frame: at age of 8-9 years

    Including higher-level cognitive processes such as attention, perseverance, WM, abstract thinking, CF, and set shifting;assessed using Wsiconsin card sorting test

  7. maternal and childhood abnormal glucose metabolism after delivery

    Time frame: 3, 6 and 9 years after delivery

    blood glucose level：glycosylated hemoglobin，fasting blood glucose, 1-hour glucose, 2-hour glucose, ect.

  8. maternal and childhood abnormal lipid metabolism after delivery

    Time frame: 3, 6 and 9 years after delivery

    Lipid level : total cholesterol, triglycerides, LDL, HDL, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianrong He, PhD

CONTACT

[email protected]

0086 20 38367159

Xiu Qiu,, PhD

CONTACT

[email protected]

0086 20 38367160

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Official study title

Human Genes and Microbiota in Early Life (HuGME)

Acronym: HuGME

Important dates

Study start
2019
Primary completion
2038
Study completion
2038
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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