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RecruitingNCT06926166HuGMEUpdated Sep 16, 2026

Human Genes and Microbiota in Early Life

An observational study in Host and Microbiome, Pregnancy Outcomes and Pregnancy Complications, sponsored by Guangzhou Women and Children's Medical Center. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Guangzhou Women and Children's Medical Center · Observational

From the registry’s dates

  • Started Apr 2019; still recruiting 7 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Host and Microbiome
  • Pregnancy Outcomes
  • Pregnancy Complications
  • Neurodevelopmental Disorders
  • Immune Development
  • Childhood Obesity
  • Type 2 Diabetes
03

In context

Pregnancy Complications

411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 400 across 198 observational studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

Guangzhou Women and Children's Medical Center is the lead sponsor of 58 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Refuses to have blood and stool samples stored at Born in Guangzhou cohort study Biobank.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • No treatment

    No treatment

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  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

    Time frame: 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.

    Time frame: during pregnancy, 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years after delivery

Secondary outcomes

  1. Neurodevelopment during early childhood

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

    Time frame: 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

    Time frame: 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

    Time frame: at age of 6 years

  4. Neurodevelopment during preschool age

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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 3, 6 and 9 years after delivery

  8. maternal and childhood abnormal lipid metabolism after delivery

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

    Time frame: 3, 6 and 9 years after delivery

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2019 (actual). Primary completion is estimated for Dec 2038, 236 months after the start.

Of 113 non-industry observational studies under Pregnancy Complications, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 201. This study's planned 236 months is above that.

Counting every sponsor, half of 121 studies reached it within 60 months; a quarter within 30 and three quarters within 151.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2025
First posted
Apr 13, 2025
StartActual
Apr 1, 2019
Primary completionEst.
Dec 31, 2038
CompletionEst.
Dec 31, 2038
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06926166
Lead sponsor
Guangzhou Women and Children's Medical Center
Responsible party
Xiu Qiu (The division of the born in Guangzhou cohort study, Guangzhou Women and Children's Medical Center) — Principal investigator
First posted
Apr 13, 2025
Start date
Apr 1, 2019
Primary completion
Dec 31, 2038 (estimated)
Completion
Dec 31, 2038 (estimated)
Last update
Sep 16, 2026

Study contacts

Xiu Qiu,, PhD
Contact
qxiu0161@163.com
0086 20 38367160
Jianrong He, PhD
Contact
jianrong.he@bigcs.org
0086 20 38367159
Xiu Qiu, PhD
principal investigator · Study Principal Investigator Guangzhou Women and Children's Medical Center, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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