NCT06943469

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
4 countries

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Apr 2025Nov 2028

First Submitted

Initial submission to the registry

March 17, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

March 17, 2025

Last Update Submit

December 11, 2025

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

  • TransEpidermal Water Loss (TEWL) at 3 months

    TransEpidermal water loss will be measured using a validated non-invasive technique.

    At 3 months of age

Secondary Outcomes (22)

  • Cumulative incidence of Atopic Dermatitis

    From enrollment to 12 months of age

  • TransEpidermal Water Loss

    From enrollment to 12 months of age

  • Skin surface (stratum corneum) hydration

    From enrollment to 12 months of age

  • Extent and severity of Atopic Dermatitis

    From 3 months to 12 months of age

  • Cumulative use of topical steroids and calcineurin inhibitors

    From enrollment to 12 months of age

  • +17 more secondary outcomes

Study Arms (3)

Test formula

EXPERIMENTAL

Partially hydrolyzed formula with synbiotics

Other: Test formula

Control formula

ACTIVE COMPARATOR

Intact protein formula without synbiotics

Other: Control formula

Reference arm

NO INTERVENTION

Breastfed arm (not applicable for France)

Interventions

Test formulaOTHER

Partially hydrolyzed formula with synbiotics

Test formula
Control formulaOTHER

Intact protein formula without synbiotics

Control formula

Eligibility Criteria

Age1 Day - 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Written informed consent has been obtained from at least one parent or legally acceptable 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 siblings are enrolled.
  • At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
  • 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.
  • 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 study documents and are willing and able to fulfill the requirements of the study protocol.

You may not qualify if:

  • Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
  • 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.
  • Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
  • Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
  • Infant's parents or LARs have not reached legal age of majority (18 years).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

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

Bruges, Belgium

RECRUITING

Universitair Ziekenhuis Brussel - Kinderziekenhuis

Brussels, Belgium

RECRUITING

Clinique Ste Elisabeth

Namur, Belgium

RECRUITING

CHU Amiens Picardie

Amiens, France

RECRUITING

CHU de Caen

Caen, France

RECRUITING

CHU de Grenoble Alpes

Grenoble, France

RECRUITING

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

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

RECRUITING

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

RECRUITING

Hospital Universitari Sant Joan de Reus

Tarragona, Spain

RECRUITING

HCU Lozano Blesa

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Amelie Goyer, PhD

CONTACT

+41217858939Amelie.Goyer1@rd.nestle.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

April 24, 2025

Study Start

April 10, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(3)ES(9)DE(5)FR(6)