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Fecal Gut MicrobiotaNCT07705685

National Cohort Study on Infant Gut Microbiota and Nutrition

An observational study of Fecal Gut Microbiota, run by DiproBio (Shanghai) Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study plans to collect 106,667 fecal samples from Chinese infants and children under 6 years old, with multi-dimensional stratification based on geographic location, mode of delivery, antibiotic exposure, and developmental stage. Read more about this study

Who is it for?
Ages 0 to 6 years
Conditions the study is for
Fecal Gut Microbiota
What is being tested?
Fecal sample collection and gut microbiome profiling
How many people
106,667 participants
Where
1 siteChina
Study dates
30 Apr 2026to 1 Mar 2031
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 6 years
  • All sexes
  • Child

Study population: A total of 106,667 Chinese infants and children aged 0 to 6 years will be enrolled across all 34 provincial-level administrative regions of China

Who may be able to join

  • Infants and children aged 0-6 years, regardless of gender.
  • Volunteers willing to participate in fecal sample collection and baseline health information gathering during the study period.
  • Legal guardians must agree to participate in the study and provide a signed written informed consent.

Who cannot join

  • Presence of congenital developmental anomalies, including but not limited to congenital cardiovascular malformations and chromosomal aneuploidy.
  • Immune system functional disorders, such as Severe Combined Immunodeficiency.
  • Diagnosis of hereditary diseases, such as genetic disorders caused by chromosomal abnormalities.
  • Any condition deemed unsuitable for participation by the investigator, including but not limited to failure to meet compliance assessment standards.

Trial locations and contacts

1 site in 1 country.

China1 site
  • DiPROBIO(Shanghai) Co., Ltd.

    Shanghai

Other trials in China

About this study

Official title: Study on Gut Microbiota Characteristics and Their Relationship With Nutritional Health in Infants and Young Children Based on a National Cohort

This study plans to collect 106,667 fecal samples from Chinese infants and children under 6 years old, with multi-dimensional stratification based on geographic location, mode of delivery, antibiotic exposure, and developmental stage. Fecal gut microbiota will be profiled to construct a gut microbiome atlas, establish quantitative analytical models linking geographic regions, physiological phenotypes and microbial signatures, and identify key microbial biomarkers associated with core healthy phenotypes.

Read the detailed description

The human gastrointestinal tract harbors vast and diverse microbial communities collectively termed the "gut microbiota", widely known as the human body's "second genome". Research has demonstrated that during the colonization and maturation of gut microbiota in early infancy, these microbes participate in multiple core physiological processes including immune system maturation, nutrient absorption and metabolism, and nervous system development. Infancy represents a critical window for the establishment of intestinal microecology. Disturbances from adverse environmental factors such as antibiotic administration, inappropriate dietary patterns, and environmental pollution may trigger dysbiosis of microbial composition, which in turn elevates the long-term risk of developing obesity, allergic disorders, asthma, autism spectrum disorders and other diseases.

The formation and dynamic shifts of childhood gut microbiota are shaped not only by early-life exposures including mode of delivery, breastfeeding status and antibiotic use, but also by subsequent dietary patterns, living environments and socioeconomic status. For instance, high-fat diets reduce the abundance of beneficial gut bacteria, whereas Mediterranean-style diets support intestinal health; antibiotic treatment markedly diminishes microbial diversity and impairs community stability; urban-rural disparities also drive profound differences in gut microbial composition.

To date, domestic research on gut microbiota among infants and children has largely consisted of regional, small-cohort studies, lacking large-scale baseline datasets covering diverse geographic regions, age brackets and health statuses across China. This gap partially hinders the accumulation of scientific evidence for pediatric intestinal health research and disease prevention and control, and restricts the formulation of localized nutritional intervention strategies.

Accordingly, this study aims to conduct a large-cohort investigation covering infants and children aged 0 to 6 years nationwide. Through metagenomic sequencing and microbial isolation and culture of fecal specimens, we will construct gut microbiota atlases stratified by age, geographic region and health profile. The research will focus on associations between representative core gut taxa (e.g., Bifidobacterium) and indicators including children's nutritional status, immune development, allergic manifestations, gastrointestinal function and physical growth. We will also characterize microbial succession patterns during critical developmental windows in early life. Multivariate modeling and machine learning algorithms will be applied to screen microbial biomarkers strongly correlated with specific health conditions, and further dissect their underlying biological mechanisms.

This project is led by a professional research team with extensive experience in intestinal microecology. The team has previously completed gut microbiota profiling and analysis for thousands of infant subjects, obtained ethical approval and secured third-party laboratory qualification, laying a solid research foundation. Findings from this study will provide data support for early identification and intervention of common childhood illnesses, and deliver vital scientific evidence for developing personalized nutritional and health management strategies tailored to gut microecological signatures in Chinese children.

Being tested
Fecal sample collection and gut microbiome profiling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal sample collection and gut microbiome profilingOther

    This study is purely observational with no therapeutic or invasive clinical interventions implemented. We only collect non-invasive fecal specimens from enrolled healthy infants and children aged 0-6 years across China, perform microbial genome sequencing and microbial isolation culture to analyze gut microbiota characteristics, and construct a national pediatric gut microbiome atlas. No drugs, medical devices or clinical treatment adjustments are given to participants throughout the research.

Study groups in NCT07705685
Study groupRoleWhat they receive
National cohort of Chinese children aged 0-6 yearsThis single nationwide cohort enrolls a total of 106,667 Chinese infants and children under 6 years old. enrollment.
Receives: Other: Fecal sample collection and gut microbiome profiling

What is being measured

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

  1. Establish a national gut microbiome atlas of infants and children aged 0-6 years covering all 34 provincial-level administrative regions in China, incorporating subjects across distinct age brackets and geographic backgrounds

    Measured: Baseline (single time point at enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start30 Apr 2026
  3. Primary completion1 Mar 2030 (estimated)
  4. Study completion1 Mar 2031 (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
Cross-sectional
Enrolment
106,667 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705685
Sponsor's protocol ID
SECCR2025-158-01
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
15 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fecal Gut Microbiota, run by DiproBio (Shanghai) Co., Ltd. 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 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?

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?

Establish a national gut microbiome atlas of infants and children aged 0-6 years covering all 34 provincial-level administrative regions in China, incorporating subjects across distinct age brackets and geographic backgrounds (time frame: Baseline (single time point at enrollment)). 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 15 Jul 2026.

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