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Baby formula breakthrough? new study tests synbiotics to stop eczema before it starts

NCT ID NCT06943469

Prevention 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This study tests whether a partially hydrolyzed formula with added synbiotics can prevent atopic dermatitis (eczema) in 400 infants at high risk for allergies. Babies are enrolled within 14 days of birth and followed for skin barrier function and eczema development. The goal is to stop the allergic march early.

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 400 people

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

Started

Apr 2025

Expected to finish

Nov 2028

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

1 day to 14 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: 1. Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable 2. Infant gestational age ≥ 37 completed weeks 3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg 4. Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment 5. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled. 6. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire 7. a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age. or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment. 8. Parents/LAR must be able to provide evidence of parental authority and identity. 9. Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol. Exclusion Criteria: 1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes. 2. Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding. 3. Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy. 4. Infant is currently participating or has previously participated in another clinical trial prior to enrollment. 5. Infant's parents or LARs have not reached legal age of majority (18 years).

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Conditions

The condition(s) this trial relates to.

atopic eczema prevention target

As listed by the trial registrant

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

Atopic dermatitis (AD)

How to take part

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

  1. The places running it

    22 sites in 5 countries. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan

    RECRUITING

    Bruges, Belgium

  • BioMedical Centers

    NOT_YET_RECRUITING

    Warsaw, Poland

  • CHRU de Tours

    RECRUITING

    Tours, France

  • CHU Amiens Picardie

    RECRUITING

    Amiens, France

  • CHU de Caen

    RECRUITING

    Caen, France

  • CHU de Grenoble Alpes

    WITHDRAWN

    Grenoble, France

  • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

    NOT_YET_RECRUITING

    Berlin, Germany

  • Clinique Ste Elisabeth

    RECRUITING

    Namur, Belgium

  • Evangelisches Krankenhaus Düsseldorf - Frauenklinik

    RECRUITING

    Düsseldorf, Germany

  • Evangelisches Waldkrankenhaus Spandau

    RECRUITING

    Spandau, Germany

  • Grupo Pediátrico Uncibay

    RECRUITING

    Málaga, Spain

  • HCU Lozano Blesa

    RECRUITING

    Zaragoza, Spain

  • HU Torrecárdenas

    RECRUITING

    Almería, Spain

  • Hospital Quiron Salud Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Teresa Herrera

    RECRUITING

    A Coruña, Spain

  • Hospital Universitari Sant Joan de Reus

    RECRUITING

    Tarragona, Spain

  • Hospital Universitari de Tarragona Joan XXIII

    RECRUITING

    Tarragona, Spain

  • Hospital Universitario Severo Ochoa

    RECRUITING

    Madrid, Spain

  • Hôpital Charles Nicolle

    RECRUITING

    Rouen, France

  • Hôpital de la Croix Rousse

    RECRUITING

    Lyon, France

  • Instituto Hispalense de Pediatria (IHP)

    WITHDRAWN

    Seville, Spain

  • Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt, Germany

  • Marien Hospital Wesel GmbH

    RECRUITING

    Wesel, Germany

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

    NOT_YET_RECRUITING

    Bialystok, Poland

  • Universitair Ziekenhuis Brussel - Kinderziekenhuis

    WITHDRAWN

    Brussels, Belgium

More trials for these conditions

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