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Baby gut study: what you feed your infant shapes their bones

NCT ID NCT05160675

Knowledge-focused Sponsor: Société des Produits Nestlé (SPN) 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 2,760 healthy infants from birth to age 3 to understand how diet and gut bacteria influence bone development. Researchers tracked what babies ate, measured their gut microbes, and checked bone strength using ultrasound. The goal was to learn how early nutrition sets the stage for lifelong bone health.

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

2,760 people

The number who actually took part.

Started

Sep 2021

Finished

Sep 2025

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

Group 1: 690 healthy infants and their mother followed from birth to 12 months Group 2: 690 healthy infants and their mother followed from 6 months to 3 years of age

Ages

0 days to 6 months

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: * It is important to carefully consider whether a subject is suitable for enrollment into this observational study. Fulfillment of the inclusion and exclusion criteria for each subject will be documented by a qualified member of the investigative staff before any subject is enrolled. Healthy infants who fulfill all the following inclusion criteria will be included: 1. Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the subject's parents/LAR have been informed of all pertinent aspects of the study. 2. Subject's parent(s)/LAR is of legal age of consent, is willing and able to fulfill the requirements of the study protocol. 3. For group 1, healthy infants aged ≤ 10 days after birth (date of birth = Day 0). For group 2, healthy infants with maximum age of 6 months 4. Full-term gestational birth (≥ 37 and ≤ 42 weeks). 5. Subject's parent(s)/LAR is able to be contacted directly by telephone throughout the study. 6. Both parents registered have a fixed work and / or residence within their jurisdiction. Exclusion Criteria: 1. Complicated pregnancy (e.g., preeclampsia, gestational diabetes, bowel disease) as assessed by medical interview/ medical record when available 2. Infant's parents/LAR not willing and/or not able to comply with scheduled visits and the requirements of the study protocol 3. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start.

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As listed by the trial registrant

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

Healthy

Contacts and locations

Locations

  • Tianjin Women and Children Health Center，

    Tianjin, China

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