Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

Last updated: December 11, 2025
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Rash

Dermatitis, Atopic

Treatment

Test formula

Control formula

Clinical Study ID

NCT06943469
2215INF
  • Ages 1-14
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Written informed consent has been obtained from at least one parent or legallyacceptable 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 siblingsare enrolled.

  6. At least one biological parent or sibling has (or had) a medically diagnosed historyof allergy, based on response to a simple screening questionnaire

  7. a. For the breastfed reference group only: infant is exclusively breastfed sincebirth with no intake of formula, and their parent(s) have the intention to continueexclusive breastfeeding until at least 4 months of age. or b. For the randomized formula-fed groups only: infant is exclusively orpredominantly formula-fed in the 24 hours prior to enrollment, with formula feedingrepresenting at least 75% of total daily feeds. The decision to introduce formulafeeding 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 studydocuments and are willing and able to fulfill the requirements of the studyprotocol.

Exclusion

Exclusion Criteria:

  1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any othercondition (e.g., gastrointestinal surgery) that could impact oral feeding, growth orstudy outcomes.

  2. Infants with special dietary needs other than standard infant formula (e.g.,extensively hydrolyzed formula, amino acid formula, special formula for metabolicdiseases) or requiring tube feeding.

  3. Infant has already been diagnosed with allergy by a physician, including AD and/orcow's milk allergy.

  4. Infant is currently participating or has previously participated in another clinicaltrial prior to enrollment.

  5. Infant's parents or LARs have not reached legal age of majority (18 years).

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Test formula
Phase:
Study Start date:
April 10, 2025
Estimated Completion Date:
November 30, 2028

Connect with a study center

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

    Bruges 2800931,
    Belgium

    Active - Recruiting

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

    Brugge,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel - Kinderziekenhuis

    Brussels,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel - Kinderziekenhuis

    Brussels 2800866,
    Belgium

    Active - Recruiting

  • Clinique Ste Elisabeth

    Namur,
    Belgium

    Site Not Available

  • Clinique Ste Elisabeth

    Namur 2790471,
    Belgium

    Active - Recruiting

  • CHU Amiens Picardie

    Amiens,
    France

    Site Not Available

  • CHU Amiens Picardie

    Amiens 3037854,
    France

    Active - Recruiting

  • CHU de Caen

    Caen,
    France

    Site Not Available

  • CHU de Caen

    Caen 3029241,
    France

    Active - Recruiting

  • CHU de Grenoble Alpes

    Grenoble,
    France

    Site Not Available

  • CHU de Grenoble Alpes

    Grenoble 3014728,
    France

    Active - Recruiting

  • Hôpital de la Croix Rousse

    Lyon,
    France

    Site Not Available

  • Hôpital de la Croix Rousse

    Lyon 2996944,
    France

    Active - Recruiting

  • Hôpital Charles Nicolle

    Rouen,
    France

    Site Not Available

  • Hôpital Charles Nicolle

    Rouen 2982652,
    France

    Active - Recruiting

  • CHRU de Tours

    Tours,
    France

    Site Not Available

  • CHRU de Tours

    Tours 2972191,
    France

    Active - Recruiting

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

    Berlin,
    Germany

    Site Not Available

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

    Berlin 2950159,
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Düsseldorf - Frauenklinik

    Düsseldorf,
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Düsseldorf - Frauenklinik

    Düsseldorf 2934246,
    Germany

    Active - Recruiting

  • Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt

    Frankfurt 2925536,
    Germany

    Active - Recruiting

  • Evangelisches Waldkrankenhaus Spandau

    Spandau,
    Germany

    Site Not Available

  • Evangelisches Waldkrankenhaus Spandau

    Spandau 7290252,
    Germany

    Active - Recruiting

  • Marien Hospital Wesel GmbH

    Wesel,
    Germany

    Site Not Available

  • Marien Hospital Wesel GmbH

    Wesel 2810678,
    Germany

    Site Not Available

  • Hospital Teresa Herrera

    A Coruña,
    Spain

    Site Not Available

  • Hospital Teresa Herrera

    A Coruña 3119841,
    Spain

    Active - Recruiting

  • HU Torrecárdenas

    Almería,
    Spain

    Site Not Available

  • HU Torrecárdenas

    Almería 2521886,
    Spain

    Active - Recruiting

  • Hospital Quiron Salud Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital Quiron Salud Barcelona

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Hospital Universitario Severo Ochoa

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Madrid 3117735,
    Spain

    Active - Recruiting

  • Grupo Pediátrico Uncibay

    Málaga,
    Spain

    Site Not Available

  • Grupo Pediátrico Uncibay

    Málaga 2514256,
    Spain

    Active - Recruiting

  • Instituto Hispalense de Pediatria (IHP)

    Sevilla,
    Spain

    Site Not Available

  • Instituto Hispalense de Pediatria (IHP)

    Seville 2510911,
    Spain

    Active - Recruiting

  • Hospital Universitari Sant Joan de Reus

    Tarragona,
    Spain

    Site Not Available

  • Hospital Universitari de Tarragona Joan XXIII

    Tarragona,
    Spain

    Site Not Available

  • Hospital Universitari Sant Joan de Reus

    Tarragona 3108288,
    Spain

    Active - Recruiting

  • Hospital Universitari de Tarragona Joan XXIII

    Tarragona 3108288,
    Spain

    Active - Recruiting

  • HCU Lozano Blesa

    Zaragoza,
    Spain

    Site Not Available

  • HCU Lozano Blesa

    Zaragoza 3104324,
    Spain

    Active - Recruiting

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