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Mapping the infant gut: a Million-Sample quest to decode Early-Life health

NCT ID NCT07705685

Knowledge-focused Sponsor: DiproBio (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study aims to collect over 100,000 fecal samples from healthy infants and children up to 6 years old across all regions of China. By analyzing the gut bacteria in these samples, researchers will build a national atlas of the developing gut microbiome. The goal is to identify links between gut microbes, nutrition, and health in early childhood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could create a reference map of healthy infant gut bacteria, helping researchers understand how gut microbes relate to early-life nutrition and development.
What could go wrong
This is an observational study, not a treatment trial. It will describe patterns but cannot prove cause and effect. The findings may not apply to children outside China.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 106,667 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

0 to 6 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Infants and children aged 0-6 years, regardless of gender. 2. Volunteers willing to participate in fecal sample collection and baseline health information gathering during the study period. 3. Legal guardians must agree to participate in the study and provide a signed written informed consent. Exclusion Criteria: 1. Presence of congenital developmental anomalies, including but not limited to congenital cardiovascular malformations and chromosomal aneuploidy. 2. Immune system functional disorders, such as Severe Combined Immunodeficiency. 3. Diagnosis of hereditary diseases, such as genetic disorders caused by chromosomal abnormalities. 4. Any condition deemed unsuitable for participation by the investigator, including but not limited to failure to meet compliance assessment standards.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fecal gut microbiota

Contacts and locations

Locations

  • DiPROBIO(Shanghai) Co., Ltd.

    Shanghai, China