Atopic DiseasesNCT03489733
Prevention of Allergic Diseases in Infants
A study testing Hydrolyzed Formula in people with Atopic Diseases, run by HiPP GmbH & Co. Vertrieb KG at 14 sites in 10 countries.
Trial summary
A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy. Read more about this study
- Who is it for?
- Ages Up to 56 daysHealthy volunteers can take part
- Conditions the study is for
- Atopic Diseases
- What is being tested?
- Hydrolyzed Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,226 participants
- Where
- 14 sitesin 10 countries
- Study dates
- 9 Jul 2018to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 56 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 10 countries.
14 sites in 10 countries
Germany5 sites
Charité Universitätsmedizin Berlin
Berlin
Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital
Bochum
Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM)
Frankfurt
Klinik für Kinder und Jugendmedizin
Hamm
Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel
Wesel
Bulgaria1 site
Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD
Sofia
Spain1 site
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
About this study
Official title: The Effect of Low Protein, Extensively Hydrolyzed Infant Formula on Allergy Prevention in At-risk Infants up to 1 Year of Age: a Randomized, Double-blind, Controlled Intervention Study and the Long-term Effect on Allergy Prevention of Early Nutrition Given in the First 120 Days of Life in At-risk Infants Until the Child is 6 Years of Age
A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.
- Conditions
- Atopic Diseases
- Being tested
- Hydrolyzed Formula, Control formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed FormulaOther
Infant formula with extensively hydrolyzed proteins and pre- and probiotics.
Control formulaOther
Infant formula with intact proteins and pre- and probiotics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Infant Formula with hydrolyzed protein and breast milk until at least 120 days of life Receives: Other: Hydrolyzed Formula |
| Control Group | Experimental | Infant Formula with intact protein and breast milk until at least 120 days of life Receives: Other: Control formula |
| Breast Fed Group | No intervention | Exclusively breast ilk until at least 120 days of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of atopic dermatitis
Presence of atopic dermatitis on physical examination
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start9 Jul 2018
- Primary completion31 Mar 2021
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,226 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsten Beyer, Prof Dr med, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489733
- Sponsor's protocol ID
- 508917
- Status last verified
- Oct 2025
- First submitted
- 26 Mar 2018
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Protein, Extensively Hydrolyzed Infant Formula on Allergy Prevention in At-risk Infants up to 1 Year of Age: a Randomized, Double-blind, Controlled Intervention Study and the Long-term Effect on Allergy Prevention of Early Nutrition Given in the First 120 Days of Life in At-risk Infants Until the Child is 6 Years of Age
- ClinicalTrials.gov ID
- NCT03489733
- Acronym / sponsor ID
- 508917
- Conditions
- Atopic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,226 participants (actual)
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KGIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Hydrolyzed FormulaInfant Formula with hydrolyzed protein and breast milk until at least 120 days of life |
| Control Group | Experimental | Other: Control formulaInfant Formula with intact protein and breast milk until at least 120 days of life |
| Breast Fed Group | No intervention | –Exclusively breast ilk until at least 120 days of life |
Who may qualify
- Ages
- Up to 56 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed FormulaInfant formula with extensively hydrolyzed proteins and pre- and probiotics. | Other | Intervention Group |
| Control formulaInfant formula with intact proteins and pre- and probiotics. | Other | Control Group |
Primary outcome
Cumulative incidence of atopic dermatitis
Time frame: 1 year
Presence of atopic dermatitis on physical examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Beyer, Prof Dr med principal investigator
Charite University, Berlin, Germany
14 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed Formula in people with Atopic Diseases, run by HiPP GmbH & Co. Vertrieb KG at 14 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Bulgaria, Czechia, Finland, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of atopic dermatitis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.