Atopic Dermatitis (AD)SPHINXNCT06943469
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
A study testing Test formula in people with Atopic Dermatitis (AD), run by Société des Produits Nestlé (SPN) at 25 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Test formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 10 Apr 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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 is currently participating or has previously participated in another clinical trial prior to enrollment.
- Infant's parents or LARs have not reached legal age of majority (18 years).
Trial locations and contacts
25 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 5 countries
Spain9 sites, 8 recruiting
- Recruiting
Hospital Teresa Herrera
A Coruña
Ana Moreno Álvarez, Dr
- Recruiting
HU Torrecárdenas
Almería
Rafael Galera Martínez, Dr
- Recruiting
Hospital Quiron Salud Barcelona
Barcelona
Hector Boix, Dr
- Recruiting
Hospital Universitario Severo Ochoa
Madrid
Inge Silveria Alonso Larruscain, Dr
- Recruiting
Grupo Pediátrico Uncibay
Málaga
Manuel Ramón Baca Cots, Dr
- Withdrawn
Instituto Hispalense de Pediatria (IHP)
Seville
- Recruiting
Hospital Universitari de Tarragona Joan XXIII
Tarragona
Esther Parada Ricart, Dr
- Recruiting
Hospital Universitari Sant Joan de Reus
Tarragona
Joaquín Escribano Subias, Dr
- Recruiting
HCU Lozano Blesa
Zaragoza
Gerardo Rodríguez Martínez, Dr
France6 sites, 5 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
André Léké, Dr
- Recruiting
CHU de Caen
Caen
Geraldine Favrais, Pr
- Withdrawn
CHU de Grenoble Alpes
Grenoble
- Recruiting
Hôpital de la Croix Rousse
Lyon
Jean-Charles Picaud, Pr
- Recruiting
Hôpital Charles Nicolle
Rouen
Mireille Castanet, Dr
- Recruiting
CHRU de Tours
Tours
Kristen Joseph-Delaffon, Dr
Germany5 sites, 5 recruiting
- Not yet recruiting
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin
Kirsten Beyer, Pr
- Recruiting
Evangelisches Krankenhaus Düsseldorf - Frauenklinik
Düsseldorf
Monika Gappa, Pr
- Recruiting
Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt
Frankfurt
Katharina Bluemchen, PD Dr
- Recruiting
Evangelisches Waldkrankenhaus Spandau
Spandau
Frank Jochum, PD Dr
- Recruiting
Marien Hospital Wesel GmbH
Wesel
Willem Geurts van Kessel, Dr
Belgium3 sites, 2 recruiting
- Recruiting
AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan
Bruges
Luc Cornette, Dr
- Withdrawn
Universitair Ziekenhuis Brussel - Kinderziekenhuis
Brussels
- Recruiting
Clinique Ste Elisabeth
Namur
Sabine Jespers, Dr
Poland2 sites, 2 recruiting
- Not yet recruiting
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Bialystok
Anna Płoszczuk, Dr, anna.ploszczuk@icloud.com
- Not yet recruiting
BioMedical Centers
Warsaw
Magdalena Szuflinska-Sidorowicz, Dr, magda.sidorowicz@gmail.com
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Test formula, Control formula
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test formulaOther
Partially hydrolyzed formula with synbiotics
Control formulaOther
Intact protein formula without synbiotics
| Study group | Role | What they receive |
|---|---|---|
| Test formula | Experimental | Partially hydrolyzed formula with synbiotics Receives: Other: Test formula |
| Control formula | Active comparator | Intact protein formula without synbiotics Receives: Other: Control formula |
| Reference arm | No intervention | Breastfed arm (not applicable for France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TransEpidermal Water Loss (TEWL) at 3 months
TransEpidermal water loss will be measured using a validated non-invasive technique.
Measured: At 3 months of age
Secondary outcomes (22)
Cumulative incidence of Atopic Dermatitis
Cumulative incidence of AD is based on physician diagnosis using the United Kingdom Working Party (UKWP) diagnosis criteria.
Measured: From enrollment to 12 months of age
TransEpidermal Water Loss
Epidermal water loss will be measured using a validated non-invasive technique.
Measured: From enrollment to 12 months of age
Skin surface (stratum corneum) hydration
Skin hydration will be measured with a corneometer device.
Measured: From enrollment to 12 months of age
Extent and severity of Atopic Dermatitis
SCORAD (SCORing for Atopic Dermatitis), scores range from 0 to 103, with higher scores indicating higher atopic dermatitis severity
Measured: From 3 months to 12 months of age
Cumulative use of topical steroids and calcineurin inhibitors
Use of medication to treat AD and other symptoms will be collected via parent self-reported questionnaire.
Measured: From enrollment to 12 months of age
Skin cytokines
Concentration of skin cytokines such as IL4 and IL5 using immunoassays
Measured: From enrollment to 12 months of age
Skin natural moisturizing factors
Concentration of skin natural moisturizing factors such as Pyrrolidone carboxylic acid, using HPLC
Measured: From enrollment to 12 months of age
Skin stratum corneum lipids
Concentration of skin stratum corneum lipids such as ceramides, cholesterol and triacylglycerol using mass spectrometry
Measured: From enrollment to 12 months of age
Skin microbiome
Overall skin microbiome composition and diversity using next-generation sequencing
Measured: From enrollment to 12 months of age
Skin metabolites
Levels of skin metabolites using targeted or untargeted approaches.
Measured: From enrollment to 12 months of age
Immune proteomics
Levels of plasma proteins using mass cytometry or immunoassaysand immunoassays.
Measured: From enrollment to 6 months of age
Immune blood cell immunophenotyping
Levels of immune cell populations using mass cytometry or immunoassays
Measured: From enrollment to 6 months of age
Specific IgE antibodies
Specific IgE antibodies will be measured using Phadiatop infant®.
Measured: At 12 months of age
Fecal microbiome
Overall fecal microbiota composition, diversity, different bacteria taxa and microbiota community types assessed using next generation sequencing (NGS) technology
Measured: From enrollment to 12 months of age
Fecal metabolites
Levels of fecal metabolites using targeted or untargeted approaches.
Measured: From enrollment to 12 months of age
Fecal biomarkers of inflammation and immunity
Levels of fecal markers of immune health and inflammation such as total secretory IgA (sIgA), calprotectin, and α-1-antitrypsin assessed by ELISA.
Measured: From enrollment to 12 months of age
Physician-diagnosed allergic manifestations
Number of participants with Physician-diagnosed allergic manifestations.
Measured: From enrollment to 12 months of age
Gastrointestinal tolerance
Infant Gastrointestinal Symptom Questionnaire (IGSQ), scores range from 13 to 65, with higher scores indicating higher gastrointestinal discomfort.
Measured: At enrollment and 4 months of age
Weight
Weight (g and z-scores)
Measured: From enrollment to 12 months of age
Height
Length (cm and z-scores)
Measured: From enrollment to 12 months of age
Head circumference
Head circumference (cm and z-scores)
Measured: From enrollment to 12 months of age
Safety assessment
Incidence of adverse events
Measured: From enrollment to 13 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start10 Apr 2025
- Primary completionOct 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943469
- Sponsor's protocol ID
- 2215INF
- Acronym
- SPHINX
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)
- ClinicalTrials.gov ID
- NCT06943469
- Acronym / sponsor ID
- SPHINX / 2215INF
- Conditions
- Atopic Dermatitis (AD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test formula | Experimental | Other: Test formulaPartially hydrolyzed formula with synbiotics |
| Control formula | Active comparator | Other: Control formulaIntact protein formula without synbiotics |
| Reference arm | No intervention | –Breastfed arm (not applicable for France) |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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 is currently participating or has previously participated in another clinical trial prior to enrollment.
- Infant's parents or LARs have not reached legal age of majority (18 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test formulaPartially hydrolyzed formula with synbiotics | Other | Test formula |
| Control formulaIntact protein formula without synbiotics | Other | Control formula |
Primary outcome
TransEpidermal Water Loss (TEWL) at 3 months
Time frame: At 3 months of age
TransEpidermal water loss will be measured using a validated non-invasive technique.
22 secondary outcomes
Cumulative incidence of Atopic Dermatitis
Time frame: From enrollment to 12 months of age
TransEpidermal Water Loss
Time frame: From enrollment to 12 months of age
Skin surface (stratum corneum) hydration
Time frame: From enrollment to 12 months of age
Extent and severity of Atopic Dermatitis
Time frame: From 3 months to 12 months of age
Cumulative use of topical steroids and calcineurin inhibitors
Time frame: From enrollment to 12 months of age
Skin cytokines
Time frame: From enrollment to 12 months of age
Skin natural moisturizing factors
Time frame: From enrollment to 12 months of age
Skin stratum corneum lipids
Time frame: From enrollment to 12 months of age
Skin microbiome
Time frame: From enrollment to 12 months of age
Skin metabolites
Time frame: From enrollment to 12 months of age
Immune proteomics
Time frame: From enrollment to 6 months of age
Immune blood cell immunophenotyping
Time frame: From enrollment to 6 months of age
Specific IgE antibodies
Time frame: At 12 months of age
Fecal microbiome
Time frame: From enrollment to 12 months of age
Fecal metabolites
Time frame: From enrollment to 12 months of age
Fecal biomarkers of inflammation and immunity
Time frame: From enrollment to 12 months of age
Physician-diagnosed allergic manifestations
Time frame: From enrollment to 12 months of age
Gastrointestinal tolerance
Time frame: At enrollment and 4 months of age
Weight
Time frame: From enrollment to 12 months of age
Height
Time frame: From enrollment to 12 months of age
Head circumference
Time frame: From enrollment to 12 months of age
Safety assessment
Time frame: From enrollment to 13 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test formula in people with Atopic Dermatitis (AD), run by Société des Produits Nestlé (SPN) at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain, France, Germany, Belgium, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Goyer, PhD (+41217858939, Amelie.Goyer1@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TransEpidermal Water Loss (TEWL) at 3 months (time frame: At 3 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.