NCT04599946

Brief Summary

To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
2,132

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
3 countries

12 active sites

Status
active not 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 Progress70%
Jan 2021Sep 2028

First Submitted

Initial submission to the registry

October 5, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 8, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2024

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Expected
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

3.6 years

First QC Date

October 5, 2020

Last Update Submit

October 6, 2024

Conditions

Dermatitis, AtopicEczema, InfantileInfant DevelopmentChild Development

Keywords

Atopic DermatitisHealthy Term InfantsInfant FormulaInfant DevelopmentChild Development

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of atopic dermatitis up to the age of 12 months

    Cumulative incidence of atopic dermatitis up to the age of 12 months diagnosed by study personnel (defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis)

    Age 12 months

Secondary Outcomes (24)

  • Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months

    Age 24 and 60 months

  • Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months

    Age 12, 24 and 60 months

  • Point incidence of atopic dermatitis

    at 4, 6, 12, 24 and 60 months of age

  • Time to onset of atopic dermatitis

    Age 12, 24 and 60 months

  • Severity of atopic dermatitis

    at 4, 6, 12, 24 and 60 months of age

  • +19 more secondary outcomes

Study Arms (2)

Experimental formula

EXPERIMENTAL

Infant and follow-on goat milk formula

Dietary Supplement: Infant formula and follow-on formula made from whole goat milk

Control formula

ACTIVE COMPARATOR

Infant and follow-on cow milk formula

Dietary Supplement: Infant formula and follow-on formula made from cow's milk ingredients

Interventions

Infant formula and follow-on formula made from whole goat milkDIETARY_SUPPLEMENT

Infant formula and follow-on formula made from whole goat milk

Experimental formula
Infant formula and follow-on formula made from cow's milk ingredientsDIETARY_SUPPLEMENT

Infant formula and follow-on formula made from cow's milk ingredients

Control formula

Eligibility Criteria

Age0 Days - 90 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Having obtained written informed consent (signed and dated) of the child's parent(s)/caregiver(s), indicating that the child's parent(s)/caregiver(s) has/have been informed of all pertinent aspects of the study
  • Born full term (≥37 weeks +0 days and ≤ 41 weeks +6 days of gestation)
  • Age at enrolment \< 3 months of age (\<90 days)
  • Birth weight ≥2.5 kg and ≤4.5 kg
  • Born from a singleton pregnancy
  • Child's parent(s)/caregiver(s) is/are of legal age of consent
  • The child's parent(s)/caregiver(s) have sufficient local language skills to understand the study information, the informed consent, and to comply with the study procedure
  • The child's parent(s)/caregiver(s) is/are willing and deemed able to fulfil the requirements of the study protocol and procedures
  • Mother has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed

You may not qualify if:

  • Diagnosed disorder considered to interfere with nutrition, growth or development of the immune system
  • Participation of the child in any other interventional trial or participation of the mother in any intervention trial with child follow-up
  • Infant has a doctor's diagnosis of atopic dermatitis or a severe widespread skin condition prior to randomization that would make the detection or assessment of atopic dermatitis difficult
  • Infant has consumed an infant formula for more than 4 weeks prior to enrolment
  • Cow milk allergy or intolerance
  • Institutionalized infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Dr. von Hauner Children's Hospital, LMU University Hospital Munich

Munich, Germany

Location

Wojewodzki Specjalistyczny Szpital Dzieciecy

Olsztyn, Poland

Location

Karol Jonscher's University Hospital

Poznan, Poland

Location

Medical College of Rzeszow University

Rzeszów, Poland

Location

Children's Memorial Health Institute

Warsaw, Poland

Location

Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital

Almería, Spain

Location

EURISTIKOS Excellence Centre for Paediatric Research, University of Granada

Granada, Spain

Location

Department of Neonatology, Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, Spain

Location

Hospital Universitari Joan XXIII de Tarragona

Tarragona, Spain

Location

INCLIVA Health Research Institute

Valencia, Spain

Location

Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon

Zaragoza, Spain

Location

Related Publications (1)

  • Ferry JM, Galera-Martinez R, Campoy C, Saenz de Pipaon M, Jarocka-Cyrta E, Walkowiak J, Romanczuk B, Escribano J, Gispert M, Grattarola P, Gruszfeld D, Iglesia I, Grote V, Demmelmair H, Handel U, Gallier S, Koletzko B. Effects of infant feeding with goat milk formula or cow milk formula on atopic dermatitis: protocol of the randomised controlled Goat Infant Formula Feeding and Eczema (GIraFFE) trial. BMJ Open. 2023 Apr 13;13(4):e070533. doi: 10.1136/bmjopen-2022-070533.

    PMID: 37055203DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Berthold Koletzko, MD, PhD

    Dr. von Hauner Children's Hospital, LMU University Hospital Munich

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 23, 2020

Study Start

January 8, 2021

Primary Completion

August 28, 2024

Study Completion (Estimated)

September 1, 2028

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations

DE(1)ES(7)PL(4)