Tests a partly broken-down infant formula with synbiotics for skin allergy in newborns
Tests a partly broken-down formula with synbiotics in newborns at risk of allergy.
Plain-language title generated from the registry record
Registry title: Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Key facts
- Where
- A Coruña, Almería, Barcelona, Madrid, Málaga, Seville, Tarragona, and Zaragoza, SpainSee the 9 sites
Where in Spain
- Hospital Teresa HerreraA Coruña, SpainTaking people
- HU TorrecárdenasAlmería, SpainTaking people
- Hospital Quiron Salud BarcelonaBarcelona, SpainTaking people
- Hospital Universitario Severo OchoaMadrid, SpainTaking people
- Grupo Pediátrico UncibayMálaga, SpainTaking people
- Instituto Hispalense de Pediatria (IHP)Seville, SpainNo longer taking part
- Hospital Universitari de Tarragona Joan XXIIITarragona, SpainTaking people
- Hospital Universitari Sant Joan de ReusTarragona, SpainTaking people
- HCU Lozano BlesaZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Société des Produits Nestlé (SPN)
- Trial code
- NCT06943469
- Record updated
- 30 July 2026
- Original description
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.Read full original descriptionShow less
Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)
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.
Inclusion: Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable; Infant gestational age ≥ 37 completed weeks; Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg; Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment; Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled; At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire; 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; Parents/LAR must be able to provide evidence of parental authority and identity; 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: Infant is currently participating or has previously participated in another clinical trial prior to enrollment; Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes; 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; Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy; Infant's parents or LARs have not reached legal age of majority (18 years).