Phase
Condition
Scalp Disorders
Allergy
Eczema (Atopic Dermatitis - Pediatric)
Treatment
Test formula
Control formula
Clinical Study ID
Ages 1-14 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent has been obtained from at least one parent or legallyacceptable 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 siblingsare enrolled.
At least one biological parent or sibling has (or had) a medically diagnosed historyof allergy, based on response to a simple screening questionnaire
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.
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 studydocuments and are willing and able to fulfill the requirements of the studyprotocol.
Exclusion
Exclusion Criteria:
Infectious, metabolic, congenital, genetic, gastrointestinal illness or any othercondition (e.g., gastrointestinal surgery) that could impact oral feeding, growth orstudy outcomes.
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.
Infant has already been diagnosed with allergy by a physician, including AD and/orcow's milk allergy.
Infant is currently participating or has previously participated in another clinicaltrial prior to enrollment.
Infant's parents or LARs have not reached legal age of majority (18 years).
Study Design
Connect with a study center
AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan
Brugge,
BelgiumSite Not Available
Universitair Ziekenhuis Brussel - Kinderziekenhuis
Brussels,
BelgiumActive - Recruiting
Clinique Ste Elisabeth
Namur,
BelgiumActive - Recruiting
CHU Amiens Picardie
Amiens,
FranceSite Not Available
CHU de Caen
Caen,
FranceSite Not Available
CHU de Grenoble Alpes
Grenoble,
FranceSite Not Available
Hôpital de la Croix Rousse
Lyon,
FranceSite Not Available
Hôpital Charles Nicolle
Rouen,
FranceSite Not Available
CHRU de Tours
Tours,
FranceSite Not Available
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin,
GermanySite Not Available
Evangelisches Krankenhaus Düsseldorf - Frauenklinik
Düsseldorf,
GermanySite Not Available
Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt
Frankfurt,
GermanySite Not Available
Evangelisches Waldkrankenhaus Spandau
Spandau,
GermanySite Not Available
Marien Hospital Wesel GmbH
Wesel,
GermanySite Not Available
Hospital Teresa Herrera
A Coruña,
SpainSite Not Available
HU Torrecárdenas
Almería,
SpainSite Not Available
Hospital Quiron Salud Barcelona
Barcelona,
SpainSite Not Available
Hospital Universitario Severo Ochoa
Madrid,
SpainSite Not Available
Grupo Pediátrico Uncibay
Málaga,
SpainSite Not Available
Instituto Hispalense de Pediatria (IHP)
Sevilla,
SpainSite Not Available
Hospital Universitari Sant Joan de Reus
Tarragona,
SpainSite Not Available
Hospital Universitari de Tarragona Joan XXIII
Tarragona,
SpainSite Not Available
HCU Lozano Blesa
Zaragoza,
SpainSite Not Available
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