Clinical trial NCT06943469: Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Official title: Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis (AD)
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2025-04-24
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: TransEpidermal Water Loss (TEWL) at 3 months
timeFrame: At 3 months of age
Secondary outcomes:
measure: Cumulative incidence of Atopic Dermatitis
timeFrame: From enrollment to 12 months of age
measure: TransEpidermal Water Loss
timeFrame: From enrollment to 12 months of age
measure: Skin surface (stratum corneum) hydration
timeFrame: From enrollment to 12 months of age
measure: Extent and severity of Atopic Dermatitis
timeFrame: From 3 months to 12 months of age
measure: Cumulative use of topical steroids and calcineurin inhibitors
timeFrame: From enrollment to 12 months of age
measure: Skin cytokines
timeFrame: From enrollment to 12 months of age
measure: Skin natural moisturizing factors
timeFrame: From enrollment to 12 months of age
measure: Skin stratum corneum lipids
timeFrame: From enrollment to 12 months of age
measure: Skin microbiome
timeFrame: From enrollment to 12 months of age
measure: Skin metabolites
timeFrame: From enrollment to 12 months of age
measure: Immune proteomics
timeFrame: From enrollment to 6 months of age
measure: Immune blood cell immunophenotyping
timeFrame: From enrollment to 6 months of age
measure: Specific IgE antibodies
timeFrame: At 12 months of age
measure: Fecal microbiome
timeFrame: From enrollment to 12 months of age
measure: Fecal metabolites
timeFrame: From enrollment to 12 months of age
measure: Fecal biomarkers of inflammation and immunity
timeFrame: From enrollment to 12 months of age
measure: Physician-diagnosed allergic manifestations
timeFrame: From enrollment to 12 months of age
measure: Gastrointestinal tolerance
timeFrame: At enrollment and 4 months of age
measure: Weight
timeFrame: From enrollment to 12 months of age
measure: Height
timeFrame: From enrollment to 12 months of age
measure: Head circumference
timeFrame: From enrollment to 12 months of age
measure: Safety assessment
timeFrame: From enrollment to 13 months of age
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel - Kinderziekenhuis
city: Namur
country: Belgium
facility: Clinique Ste Elisabeth
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Caen
country: France
facility: CHU de Caen
city: Grenoble
country: France
facility: CHU de Grenoble Alpes
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Tours
country: France
facility: CHRU de Tours
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf - Frauenklinik
city: Frankfurt
country: Germany
facility: Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt
city: Spandau
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
city: Wesel
country: Germany
facility: Marien Hospital Wesel GmbH
city: A Coruña
country: Spain
facility: Hospital Teresa Herrera
city: Almería
country: Spain
facility: HU Torrecárdenas
city: Barcelona
country: Spain
facility: Hospital Quiron Salud Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Málaga
country: Spain
facility: Grupo Pediátrico Uncibay
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria (IHP)
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
city: Tarragona
country: Spain
facility: Hospital Universitari Sant Joan de Reus
city: Zaragoza
country: Spain
facility: HCU Lozano Blesa
Study officials:
References: