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New baby formula tested for better growth and health in toddlers

NCT ID NCT07534735

Knowledge-focused Sponsor: Biostime (Changsha) Nutrition Foods Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a new infant formula can help healthy babies aged 12-18 months grow well and improve their gut health, immune system, and sleep. About 120 infants will be randomly assigned to different formulas. The goal is to see if the new formula offers any benefits over standard options.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Started

May 2026

Expected to finish

Jan 2027

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.

Ages

12 to 18 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy full-term infants (gestational age 37-42 weeks). * Age 12-18 months (inclusive). * Weight below the 75th percentile according to the "Growth Reference Standards for Chinese Children Under 7 Years Old". * Has started or plans to start stage 3 formula feeding before enrollment. * Guardian voluntarily signs written informed consent and is able to comply with all study procedures including regular visits, intervention plan, and laboratory tests. Exclusion Criteria: * Known allergy to milk protein or the study formula. * Known allergic constitution or high allergy risk (parent with allergic constitution). * Malnutrition assessed by investigator. * Chronic infectious disease, metabolic disease, genetic disease, or any other condition affecting feeding or growth and development. * History of preterm birth or admission to Neonatal Intensive Care Unit (NICU), excluding phototherapy for jaundice. * Severe constipation or diagnosis of other functional gastrointestinal disorders. * Cognitive or developmental disorders. * Any other condition that, in the investigator's judgment, makes the infant unsuitable for participation.

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As listed by the trial registrant

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

Infant growth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Shenzhen University

    RECRUITING

    Shenzhen, Guangdong, 518060, China

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