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
- Bialystok and Warsaw, PolandSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for newborn babies, up to 14 days old, with a parent or sibling who has an allergy. It tests a baby formula with added good bacteria for skin health.
- Age
- Babies up to 14 days old at enrollment (1 Day to 14 Days).
- Sex
- All babies can join, boys and girls.
- Disease stage
- Babies who have not been diagnosed with any allergy, including atopic dermatitis or cow's milk allergy. At least one biological parent or sibling has (or had) a medically diagnosed allergy.
- Earlier treatment
- Formula-fed groups: the baby is exclusively or mostly formula-fed, at least 75% of daily feeds. Breastfed reference group: exclusively breastfed since birth with no formula, and parents plan to continue until at least 4 months of age.
Main reasons for not taking part
- Born before 37 completed weeks
- Birth weight under 2.5 kg (6 lb) or over 4.5 kg (10 lb)
- Illness or condition that could affect feeding, growth or study results
- Needs a special diet or tube feeding, other than standard infant formula
- Already diagnosed with an allergy, or in another clinical trial now or before
Read by machine on 9 November 2026.
Where in Poland
- Prywatna praktyka lekarska. Gabinet pediatryczno - alergologicznyBialystok, PolandNot yet recruiting
- BioMedical CentersWarsaw, PolandNot yet recruiting
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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).