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Clinical Trials in Germany / NCT06943469
Recruiting Not applicable

Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

NCT06943469 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2025-04-10
Last updated
2026-07-30

Condition(s) studied

Atopic Dermatitis (AD)

Investigational drug(s) / intervention(s)

Test formulaControl formula

Test formula: Partially hydrolyzed formula with synbiotics

Control formula: Intact protein formula without synbiotics

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

Sex
ALL
Min age
1 Day
Max age
14 Days
Healthy volunteers
Accepted
Inclusion Criteria: 1. Written informed consent has been obtained from at least one parent or legally acceptable 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 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: 1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes. 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).

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan Bruges Belgium Recruiting
Universitair Ziekenhuis Brussel - Kinderziekenhuis Brussels Belgium Withdrawn
Clinique Ste Elisabeth Namur Belgium Recruiting
CHU Amiens Picardie Amiens France Recruiting
CHU de Caen Caen France Recruiting
CHU de Grenoble Alpes Grenoble France Withdrawn
Hôpital de la Croix Rousse Lyon France Recruiting
Hôpital Charles Nicolle Rouen France Recruiting
CHRU de Tours Tours France Recruiting
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) Berlin Germany Not Yet Recruiting
Evangelisches Krankenhaus Düsseldorf - Frauenklinik Düsseldorf Germany Recruiting
Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt Frankfurt Germany Recruiting
Evangelisches Waldkrankenhaus Spandau Spandau Germany Recruiting
Marien Hospital Wesel GmbH Wesel Germany Recruiting
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Bialystok Poland Not Yet Recruiting
BioMedical Centers Warsaw Poland Not Yet Recruiting
Hospital Teresa Herrera A Coruña Spain Recruiting
HU Torrecárdenas Almería Spain Recruiting
Hospital Quiron Salud Barcelona Barcelona Spain Recruiting
Hospital Universitario Severo Ochoa Madrid Spain Recruiting
Grupo Pediátrico Uncibay Málaga Spain Recruiting
Instituto Hispalense de Pediatria (IHP) Seville Spain Withdrawn
Hospital Universitari de Tarragona Joan XXIII Tarragona Spain Recruiting
Hospital Universitari Sant Joan de Reus Tarragona Spain Recruiting
HCU Lozano Blesa Zaragoza Spain Recruiting

More Société des Produits Nestlé (SPN) trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06943469 on ClinicalTrials.gov ↗ ← All trials in Germany