Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Baby formula with extra ingredients may cut infections and boost growth

NCT ID NCT06137235

Disease control Sponsor: FrieslandCampina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether infant formula with added bioactive ingredients helps healthy babies grow well, tolerate the formula, and have fewer infections. About 456 full-term infants will receive either the test formula or a standard formula. Parents will report any infection symptoms and the babies' growth will be measured.

What this could mean

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

Active substance
infant formula with bioactive ingredients
What this could lead to
If it works, this could lead to a better infant formula that helps reduce common infections and supports healthy growth in babies.
What could go wrong
This is a relatively small, early-stage trial with no phase designation, so results may not be conclusive. The benefits over standard formula may be small or not statistically significant.

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 456 people

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

Started

Dec 2023

Expected to finish

Dec 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

5 to 60 days

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: * Full-term infants * Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g * Boys and girls * Apparently healthy at birth and screening * Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards * Age at enrolment: ≤60 days of age * If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion * If 1 month \< age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2 * Being available for follow up until the age of 12 months * Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years Exclusion Criteria: * Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID)) * Incapability of parents to comply with the study protocol * Illiterate parents (i.e. not able to read and write in local language) * Participation in another clinical trial * Unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months * Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for GROWTH are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Infections infectious disease

As listed by the trial registrant

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

GROWTH Infections

Contacts and locations

Locations

  • Harokopio University

    Athens, Greece

  • International Hellenic University

    Thessaloniki, Greece

  • University of Thessaly

    Trikala, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.