Actively Recruiting
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-12
400
Participants Needed
23
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.
CONDITIONS
Official Title
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from a parent or legally acceptable representative
- Infant gestational age of 37 completed weeks or more
- Infant birth weight between 2.5 kg and 4.5 kg
- Infant postnatal age 14 days or less at enrollment
- Infant from singleton birth or from multiple births if all siblings are enrolled
- At least one biological parent or sibling has a medically diagnosed history of allergy
- Infant is exclusively breastfed since birth with intent to continue until at least 4 months or is predominantly formula-fed (at least 75% of daily feeds) in the 24 hours before enrollment
- Parents or representatives able to provide proof of authority and identity
- Parents or representatives understand the consent form and agree to follow study requirements
You will not qualify if you...
- Infant has infectious, metabolic, congenital, genetic, gastrointestinal illness, or any condition affecting feeding, growth, or study outcomes
- Infant requires special dietary needs other than standard formula or tube feeding
- Infant has been diagnosed with allergy including atopic dermatitis or cow's milk allergy
- Infant currently or previously participated in another clinical trial
- Infant's parents or representatives are under 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan
Bruges, Belgium
Actively Recruiting
2
Universitair Ziekenhuis Brussel - Kinderziekenhuis
Brussels, Belgium
Actively Recruiting
3
Clinique Ste Elisabeth
Namur, Belgium
Actively Recruiting
4
CHU Amiens Picardie
Amiens, France
Actively Recruiting
5
CHU de Caen
Caen, France
Actively Recruiting
6
CHU de Grenoble Alpes
Grenoble, France
Actively Recruiting
7
Hôpital de la Croix Rousse
Lyon, France
Actively Recruiting
8
Hôpital Charles Nicolle
Rouen, France
Actively Recruiting
9
CHRU de Tours
Tours, France
Actively Recruiting
10
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, Germany
Not Yet Recruiting
11
Evangelisches Krankenhaus Düsseldorf - Frauenklinik
Düsseldorf, Germany
Actively Recruiting
12
Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt
Frankfurt, Germany
Actively Recruiting
13
Evangelisches Waldkrankenhaus Spandau
Spandau, Germany
Actively Recruiting
14
Marien Hospital Wesel GmbH
Wesel, Germany
Not Yet Recruiting
15
Hospital Teresa Herrera
A Coruña, Spain
Actively Recruiting
16
HU Torrecárdenas
Almería, Spain
Actively Recruiting
17
Hospital Quiron Salud Barcelona
Barcelona, Spain
Actively Recruiting
18
Hospital Universitario Severo Ochoa
Madrid, Spain
Actively Recruiting
19
Grupo Pediátrico Uncibay
Málaga, Spain
Actively Recruiting
20
Instituto Hispalense de Pediatria (IHP)
Seville, Spain
Actively Recruiting
21
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain
Actively Recruiting
22
Hospital Universitari Sant Joan de Reus
Tarragona, Spain
Actively Recruiting
23
HCU Lozano Blesa
Zaragoza, Spain
Actively Recruiting
Research Team
A
Amelie Goyer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here