Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
NCT ID: NCT06943469
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2025-04-10
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Test formula
Partially hydrolyzed formula with synbiotics
Test formula
Partially hydrolyzed formula with synbiotics
Control formula
Intact protein formula without synbiotics
Control formula
Intact protein formula without synbiotics
Reference arm
Breastfed arm (not applicable for France)
No interventions assigned to this group
Interventions
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Test formula
Partially hydrolyzed formula with synbiotics
Control formula
Intact protein formula without synbiotics
Eligibility Criteria
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Inclusion Criteria
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 siblings are enrolled.
6. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
7. 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.
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 study documents and are willing and able to fulfill the requirements of the study protocol.
Exclusion Criteria
2. 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.
3. Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
4. Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
5. Infant's parents or LARs have not reached legal age of majority (18 years).
1 Day
14 Days
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Luc Cornette, Dr
Role: primary
Yvan Vandenplas, Pr
Role: primary
Sabine Jespers, Dr
Role: primary
André Léké, Dr
Role: primary
Geraldine Favrais, Pr
Role: primary
Blandine Rébeillé Borgella
Role: primary
Jean-Charles Picaud, Pr
Role: primary
Mireille Castanet, Dr
Role: primary
Kristen Joseph-Delaffon, Dr
Role: primary
Kirsten Beyer, Pr
Role: primary
Monika Gappa, Pr
Role: primary
Katharina Bluemchen, PD Dr
Role: primary
Frank Jochum, PD Dr
Role: primary
Cordula Koerner-Rettberg, Dr
Role: primary
Ana Moreno Álvarez, Dr
Role: primary
Rafael Galera Martínez, Dr
Role: primary
Hector Boix, Dr
Role: primary
Maria Luz Garcia, Dr
Role: primary
Manuel Ramón Baca Cots, Dr
Role: primary
Ignacio Salamanca de la Cueva, Dr
Role: primary
Esther Parada Ricart, Dr
Role: primary
Joaquín Escribano Subias, Dr
Role: primary
Gerardo Rodríguez Martínez, Dr
Role: primary
Other Identifiers
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2215INF
Identifier Type: -
Identifier Source: org_study_id
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