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Special formula may shield At-Risk babies from allergies

NCT ID NCT03489733

Prevention Sponsor: HiPP GmbH & Co. Vertrieb KG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a low-protein, extensively hydrolyzed infant formula with added pre- and probiotics can prevent allergies in babies at high risk. Over 1,200 healthy newborns were given either the special formula or a standard formula during their first months of life. Researchers tracked how many developed atopic dermatitis (eczema) by age one, and will follow them until age six to see long-term effects.

What this could mean

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

Active substance
extensively hydrolyzed infant formula with pre- and probiotics
What this could lead to
If successful, this could show that a specific infant formula reduces the chance of developing allergies in at-risk babies.
What could go wrong
The study is completed but results are not yet widely confirmed. The effect may be small or not apply to all infants. No serious risks are expected from a standard infant formula.

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

1,226 people

The number who actually took part.

Started

Jul 2018

Finished

Oct 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.

Ages

Up to 56 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: * Healthy term-born male and female infants (gestational Age ≥37+0, singleton birth) * Birth weight ≥ 2500 g and ≤ 4500 g * Age at enrollment: ≤ 56 days of life * At risk of developing atopic diseases * Free of atopy symptoms at Screening and at any time before randomization * Feeding regimen at any time before Screening (V1) and Baseline (V2, infants who will receive Interventional Product (IP)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. Neocate Infant), maltodextrin or glucose solution/gel; breastfeeding allowed * Subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. Subject's parents/caregivers will decide which feeding regimen will be used (IP or breast milk): * IP regimen (intervention or control group): only IP and breast milk until at least 120 days of life * breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life. * No other infant formulas or solid foods are allowed. * Written informed consent. Exclusion Criteria: * Multiple births * Premature delivery (gestational age ≤ 36+6) * Neonatal illnesses that might have an impact on allergy development (based on Investigator's decision) * Significant congenital abnormalities * Participation in another clinical study with an IP or study method that would influence the outcome of this study * Reason to presume that the subject's parents/caregivers are unable to meet study plan requirements.

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Conditions

The condition(s) this trial relates to.

atopic IgE-mediated allergic disorder prevention target

As listed by the trial registrant

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

Atopic diseases

Contacts and locations

Locations

  • CHU Estaing

    Clermont-Ferrand, France

  • Charité Universitätsmedizin Berlin

    Berlin, Germany

  • Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"

    Belgrade, Serbia

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, Spain

  • Hospital braga

    Braga, Portugal

  • Instytut Mikroekologii

    Poznan, Poland

  • Klinik für Kinder und Jugendmedizin

    Hamm, Germany

  • Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel

    Wesel, Germany

  • Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital

    Bochum, Germany

  • Nemocnice Strakonice, a.s.

    Strakonice, Czechia

  • Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD

    Sofia, Bulgaria

  • Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM)

    Frankfurt, Germany

  • Suomen Terveystalo Oy

    Tampere, Finland

  • Unità Allergologia-Unità Allergologia-

    Roma, Italy