RecruitingNot ApplicableNCT06943469

Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)


Sponsor

Société des Produits Nestlé (SPN)

Enrollment

400 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 DayMax Age: 14 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Control formula and Test formula for people with atopic dermatitis (ad). The study is currently recruiting participants at 23 locations. People eligible for this study include aged 1 Day to 14 Days.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTest formula

Partially hydrolyzed formula with synbiotics

OTHERControl formula

Intact protein formula without synbiotics


Locations(23)

AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan

Bruges, Belgium

Universitair Ziekenhuis Brussel - Kinderziekenhuis

Brussels, Belgium

Clinique Ste Elisabeth

Namur, Belgium

CHU Amiens Picardie

Amiens, France

CHU de Caen

Caen, France

CHU de Grenoble Alpes

Grenoble, France

Hôpital de la Croix Rousse

Lyon, France

Hôpital Charles Nicolle

Rouen, France

CHRU de Tours

Tours, France

Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

Berlin, Germany

Evangelisches Krankenhaus Düsseldorf - Frauenklinik

Düsseldorf, Germany

Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt

Frankfurt, Germany

Evangelisches Waldkrankenhaus Spandau

Spandau, Germany

Marien Hospital Wesel GmbH

Wesel, Germany

Hospital Teresa Herrera

A Coruña, Spain

HU Torrecárdenas

Almería, Spain

Hospital Quiron Salud Barcelona

Barcelona, Spain

Hospital Universitario Severo Ochoa

Madrid, Spain

Grupo Pediátrico Uncibay

Málaga, Spain

Instituto Hispalense de Pediatria (IHP)

Seville, Spain

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

Hospital Universitari Sant Joan de Reus

Tarragona, Spain

HCU Lozano Blesa

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT06943469


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