Gut MicrobiotaNCT07762729
Gut Microbiota and Metabolic Development in Early Childhood: A 3-Year Follow-Up Study
An observational study of Gut Microbiota and Early Child Development, run by Children's Hospital of Fudan University at 5 sites in China.
Trial summary
This prospective observational birth cohort study aims to characterize the longitudinal development of the gut microbiome during early childhood and to investigate its associations with prenatal, perinatal, and postnatal exposures and child growth and health outcomes. Read more about this study
- Who is it for?
- Ages 0 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Early Child Development
- How many people
- 1,000 participants
- Where
- 5 sitesChina
- Study dates
- 16 Nov 2023to 31 Dec 2027
- How long will I take part?
- 36 Months
- 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 0 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pregnant women and their newborns receiving care at maternal and child health hospitals in Yiyang, Jiangshan, Baoji, and Qidong
Who may be able to join
- Willing to undergo regular follow-up during the study period
Who cannot join
- Difficulty in follow-up participation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Baoji Maternal and Child Health Hospital
Baoji, Shanxi, 721099
Qidong Maternal and Child Health Hospital
Nantong, Jiangsu, 226200
Jiangshan Maternal and Child Health Hospital
Quzhou, Zhejiang, 324199
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Yiyang Maternal and Child Health Hospital
Yiyang, Hunan, 413000
About this study
This prospective observational birth cohort study aims to characterize the longitudinal development of the gut microbiome during early childhood and to investigate its associations with prenatal, perinatal, and postnatal exposures and child growth and health outcomes.
Approximately 1000 pregnant women will be enrolled, and their children will be followed from birth to 36 months of age. Information on parental demographic and lifestyle characteristics, maternal pre-pregnancy and pregnancy-related factors, prenatal examinations, delivery characteristics, infant feeding, medication use, illnesses, and household and environmental factors will be collected through questionnaires and medical records.
Read more
Child anthropometric measurements and fecal samples will be collected at birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age. The fecal microbiome will be characterized using shotgun metagenomic sequencing.Umbilical cord blood will be collected at delivery from all participants, subject to informed consent and hospital procedures. At 36 months of age, residual venous blood remaining after routine health examinations and clinically indicated laboratory testing will be retained for research from all participating children.
The study will evaluate the developmental trajectories of the early-life gut microbiome and identify maternal, paternal, perinatal, feeding-related, medication-related, and environmental factors associated with microbiome development and subsequent child growth and health.
Read the detailed description
Early childhood is a critical period for the establishment and maturation of the gut microbiome. Microbiome development during this period may be influenced by maternal health, pregnancy-related factors, mode of delivery, gestational age, infant feeding, medication exposure, infections, household conditions, and other early-life exposures.
This prospective, longitudinal, observational birth cohort study will recruit approximately 1000 pregnant women and follow their children from birth to 36 months of age. No intervention will be assigned by the investigators, and participants will receive routine maternal and child healthcare according to local clinical practice.
Information on parental demographic, health, anthropometric, and lifestyle characteristics; maternal pre-pregnancy and pregnancy-related factors; prenatal examinations; delivery and neonatal characteristics; infant feeding and diet; medication use; illnesses; vaccination; hospitalization; and household and environmental factors will be collected through questionnaires and medical records. Child growth will be assessed using standardized anthropometric measurements.
Fecal samples will be collected at birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age using standardized procedures. Shotgun metagenomic sequencing will be used to characterize the taxonomic composition and functional potential of the gut microbiome and to evaluate its longitudinal developmental patterns.
Umbilical cord blood collection will be planned at delivery for all participants, subject to informed consent, collection feasibility, and institutional procedures. At 36 months of age, residual venous blood remaining after routine health examinations and clinically indicated laboratory testing may be retained for research. All biological specimens will be processed and stored according to standardized operating procedures.
Longitudinal statistical methods will be used to evaluate age-related microbiome changes and their associations with early-life exposures and child outcomes. Analyses will account for repeated measurements, relevant potential confounders, missing data, loss to follow-up, multiple comparisons, and the compositional nature of microbiome data. Exploratory analyses may assess whether gut microbiome characteristics mediate or modify associations between early-life exposures and subsequent child outcomes.
As this is an observational study, identified associations will not by themselves establish causal relationships. The study is expected to provide evidence on gut microbiome development during early childhood and to inform future mechanistic and preventive research.
- Conditions
- Gut Microbiota, Early Child Development
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relative abundance of gut microbial taxa measured by shotgun metagenomic sequencing
Gut microbial taxonomic composition will be characterized from stool samples using shotgun metagenomic sequencing and summarized as the relative abundance of microbial taxa.
Measured: At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Secondary outcomes (4)
Change in infant body weight measured by standardized follow-up records
Infant body weight will be measured in kilograms at postnatal follow-up visits and summarized as longitudinal change in body weight over time.
Measured: At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Change in infant body length measured by standardized follow-up records
Infant body length will be measured in centimeters at postnatal follow-up visits and summarized as longitudinal change in body length over time.
Measured: At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Change in infant head circumference measured by standardized follow-up records
Infant head circumference will be measured in centimeters at postnatal follow-up visits and summarized as longitudinal change in head circumference over time.
Measured: At 1, 3, 6, 9, 12, 18, 24, 30, and 36 months after birth
Infant feeding pattern assessed by standardized follow-up questionnaire
Infant feeding pattern will be assessed using follow-up questionnaires, including exclusive breastfeeding, predominant breastfeeding, mixed feeding, formula feeding, and complementary food intake.
Measured: At 1, 3, 6, 9, 12, 18, 24, 30, and 36 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start16 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feihong Luo, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762729
- Sponsor's protocol ID
- GMMD-EC3Y
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota and Metabolic Development in Early Childhood: A 3-Year Follow-Up Study
- ClinicalTrials.gov ID
- NCT07762729
- Acronym / sponsor ID
- GMMD-EC3Y
- Conditions
- Gut Microbiota, Early Child Development
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational birth cohort study aims to characterize the longitudinal development of the gut microbiome during early childhood and to investigate its associations with prenatal, perinatal, and postnatal exposures and child growth and health outcomes.
Approximately 1000 pregnant women will be enrolled, and their children will be followed from birth to 36 months of age. Information on parental demographic and lifestyle characteristics, maternal pre-pregnancy and pregnancy-related factors, prenatal examinations, delivery characteristics, infant feeding, medication use, illnesses, and household and environmental factors will be collected through questionnaires and medical records.
Child anthropometric measurements and fecal samples will be collected at birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age. The fecal microbiome will be characterized using shotgun metagenomic sequencing.Umbilical cord blood will be collected at delivery from all participants, subject to informed consent and hospital procedures. At 36 months of age, residual venous blood remaining after routine health examinations and clinically indicated laboratory testing will be retained for research from all participating children.
The study will evaluate the developmental trajectories of the early-life gut microbiome and identify maternal, paternal, perinatal, feeding-related, medication-related, and environmental factors associated with microbiome development and subsequent child growth and health.
Detailed description
Early childhood is a critical period for the establishment and maturation of the gut microbiome. Microbiome development during this period may be influenced by maternal health, pregnancy-related factors, mode of delivery, gestational age, infant feeding, medication exposure, infections, household conditions, and other early-life exposures.
This prospective, longitudinal, observational birth cohort study will recruit approximately 1000 pregnant women and follow their children from birth to 36 months of age. No intervention will be assigned by the investigators, and participants will receive routine maternal and child healthcare according to local clinical practice.
Information on parental demographic, health, anthropometric, and lifestyle characteristics; maternal pre-pregnancy and pregnancy-related factors; prenatal examinations; delivery and neonatal characteristics; infant feeding and diet; medication use; illnesses; vaccination; hospitalization; and household and environmental factors will be collected through questionnaires and medical records. Child growth will be assessed using standardized anthropometric measurements.
Fecal samples will be collected at birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age using standardized procedures. Shotgun metagenomic sequencing will be used to characterize the taxonomic composition and functional potential of the gut microbiome and to evaluate its longitudinal developmental patterns.
Umbilical cord blood collection will be planned at delivery for all participants, subject to informed consent, collection feasibility, and institutional procedures. At 36 months of age, residual venous blood remaining after routine health examinations and clinically indicated laboratory testing may be retained for research. All biological specimens will be processed and stored according to standardized operating procedures.
Longitudinal statistical methods will be used to evaluate age-related microbiome changes and their associations with early-life exposures and child outcomes. Analyses will account for repeated measurements, relevant potential confounders, missing data, loss to follow-up, multiple comparisons, and the compositional nature of microbiome data. Exploratory analyses may assess whether gut microbiome characteristics mediate or modify associations between early-life exposures and subsequent child outcomes.
As this is an observational study, identified associations will not by themselves establish causal relationships. The study is expected to provide evidence on gut microbiome development during early childhood and to inform future mechanistic and preventive research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 0 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pregnant women and their newborns receiving care at maternal and child health hospitals in Yiyang, Jiangshan, Baoji, and Qidong
Key inclusion criteria (1 listed)
- Willing to undergo regular follow-up during the study period
Key exclusion criteria (1 listed)
- Difficulty in follow-up participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in relative abundance of gut microbial taxa measured by shotgun metagenomic sequencing
Time frame: At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Gut microbial taxonomic composition will be characterized from stool samples using shotgun metagenomic sequencing and summarized as the relative abundance of microbial taxa.
4 secondary outcomes
Change in infant body weight measured by standardized follow-up records
Time frame: At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Change in infant body length measured by standardized follow-up records
Time frame: At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age
Change in infant head circumference measured by standardized follow-up records
Time frame: At 1, 3, 6, 9, 12, 18, 24, 30, and 36 months after birth
Infant feeding pattern assessed by standardized follow-up questionnaire
Time frame: At 1, 3, 6, 9, 12, 18, 24, 30, and 36 months after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota and Early Child Development, run by Children's Hospital of Fudan University at 5 sites 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: enrolling by invitation, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in relative abundance of gut microbial taxa measured by shotgun metagenomic sequencing (time frame: At birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.