Host and MicrobiomeHuGMENCT06926166
Human Genes and Microbiota in Early Life
An observational study of Host and Microbiome and Pregnancy Outcomes, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Host and Microbiome, Pregnancy Outcomes, Pregnancy Complications
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2038
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping
Who may be able to join
- 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
Who cannot join
- Refuses to have blood and stool samples stored at Born in Guangzhou cohort study Biobank.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center, China
Guangzhou
Xiu Qiu, MD,PhD, 86-020-38367160, xiu.qiu@bigcs.org
Jian-Rong He, MD, PhD, 86-020-38367160, jianrong.he@bigcs.org
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Host and Microbiome, Pregnancy Outcomes, Pregnancy Complications, Neurodevelopmental Disorders, Immune Development, Childhood Obesity
- Being tested
- No intervention
- Medical subject headings
- Pregnancy Complications, Neurodevelopmental Disorders, Pediatric Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No treatment Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: during pregnancy, 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years after delivery
Secondary outcomes (8)
Neurodevelopment during early childhood
Including adaptive, gross motor, fine motor,language,and social function; assessed using Gesell Developmental Schedules
Measured: 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
Measured: at age of 3 years
Neurodevelopment during preschool age
Including solving skills, pattern perception, and logical thinking；assessed using Raven's Standard Progressive Matrices
Measured: at age of 6 years
Neurodevelopment during preschool age
Including solving skills, pattern perception, and logical thinking；assessed using Peabody Picture Vocabulary Test
Measured: 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
Measured: 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
Measured: 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.
Measured: 3, 6 and 9 years after delivery
maternal and childhood abnormal lipid metabolism after delivery
Lipid level : total cholesterol, triglycerides, LDL, HDL, etc.
Measured: 3, 6 and 9 years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Apr 2019
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Host and MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiu Qiu, Guangzhou Women and Children's Medical Center
- Investigators
- Xiu Qiu, PhD, Principal investigator, Study Principal Investigator Guangzhou Women and Children's Medical Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926166
- Sponsor's protocol ID
- 201807010086
- Other IDs
- 82003471, 2021A1515110194, SL2024A04J0217
- Acronym
- HuGME
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28321694Kuang 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.
PubMed 28873967Gao 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.
PubMed 37929652Kuang 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.
PubMed 27827448Guo 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.
PubMed 27226242