Actively Recruiting
Synbiotics in Partially Hydrolysed Formula for Improved Skin Barrier Function in Infants at Risk for Allergy (SPHINX Study)
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-12
400
Participants Needed
23
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a partially hydrolyzed formula with synbiotics on improving skin barrier function in infants at risk of allergy. The study aims to assess how this formula might prevent early allergic conditions like atopic dermatitis, which is an early step in the allergic march. Safety and other related health parameters will also be monitored during the study. Participants will be assigned to one of three groups: a test group receiving partially hydrolyzed formula with synbiotics, a control group receiving intact protein formula without synbiotics, or a breastfed reference group (not applicable in France). The study is randomized and includes infants from birth up to 14 days old, followed through their first year. During the study, researchers will measure skin barrier function using TransEpidermal Water Loss at 3 months of age as the primary outcome. They will also monitor incidence and severity of atopic dermatitis, skin hydration, immune markers, microbiome profiles, growth measurements, gastrointestinal tolerance, and safety up to 12 to 13 months of age. Parents will provide consent and participate in study requirements including feeding and follow-up visits.
CONDITIONS
Brief 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 at least one parent or legally acceptable representative
- Infant gestational age of at least 37 completed weeks
- Infant birth weight between 2.5 kg and 4.5 kg
- Infant postnatal age of 14 days or less at enrollment
- Infant from singleton birth or, if multiple births, all siblings enrolled
- At least one biological parent or sibling has a medically diagnosed history of allergy
- For breastfed group only: infant exclusively breastfed since birth with intention to continue until at least 4 months
- For formula-fed groups only: infant exclusively or predominantly formula-fed with formula feeding at least 75% of daily feeds
- Parents/LAR able to provide evidence of parental authority and identity
- Parents/LAR understand study documents and agree to study protocol
You will not qualify if you...
- Infectious, metabolic, congenital, genetic, gastrointestinal illness or conditions affecting feeding, growth, or study outcomes
- Infants requiring special dietary formulas other than standard infant formula or tube feeding
- Infant already diagnosed with allergy including atopic dermatitis or cow's milk allergy
- Infant currently or previously participated in another clinical trial
- Infant's parents or legally acceptable representatives are under 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to 12 months of age
Participants receive either a partially hydrolyzed formula with synbiotics, an intact protein formula without synbiotics, or are breastfed as part of the study groups to assess skin barrier function and allergy risk.
Regular visits during the first year to monitor skin and allergy-related outcomes
Duration - Up to 13 months of age
Participants continue to be monitored for safety and allergy-related outcomes after completing the treatment period.
Visits for safety assessment up to 13 months of age
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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