AzTrials
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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
How many people
20,000 participants
Where
1 siteChina
Study dates
1 Apr 2019to 31 Dec 2038
Phase
Observational
Are there results?
Not yet: the study is under way

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.

Xiu Qiu,, PhD contact

0086 20 38367160

qxiu0161@163.com

Jianrong He, PhD contact

0086 20 38367159

jianrong.he@bigcs.org

China1 site, 1 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

    Recruiting

Other trials in China

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:

  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.
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 groups in NCT06926166
Study groupRoleWhat they receive
No treatmentNo treatment
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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

  4. Neurodevelopment during preschool age

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

    Measured: at age of 6 years

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted13 Apr 2025
  2. Study start1 Apr 2019
  3. Primary completion31 Dec 2038 (estimated)
  4. Study completion31 Dec 2038 (estimated)

Resources

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)
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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27226242

Questions about this trial

What is this clinical trial studying?

An observational study of Host and Microbiome and Pregnancy Outcomes, run by Guangzhou Women and Children's Medical Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiu Qiu,, PhD (0086 20 38367160, qxiu0161@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbers of participants with Childhood diseases. Including: (time frame: 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06926166, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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