Goat Infant Formula Feeding and Eczema (the GIraFFE Study) (GIraFFE)

Effects of Infant Feeding with Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dermatitis, Atopic; Child Development; Infant Development; Eczema, Infantile
• Intervention / Treatment: Dietary supplement: Infant formula and follow-on formula made from whole goat milk; Dietary supplement: Infant formula and follow-on formula made from cow's milk ingredients

Detailed Description

The study is a randomized, double-blind, parallel-group trial to study the effect of feeding infants goat milk or cow milk formula in the first year of life on the risk of allergy and other health outcomes, including growth, tolerance and quality of life in the first 5 years of life.

• Study Type: Interventional
• Enrollment (Actual): 2132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • Dr. von Hauner Children's Hospital, LMU University Hospital Munich
• Poland
  • Olsztyn, Poland
    • Wojewodzki Specjalistyczny Szpital Dzieciecy
  • Poznań, Poland
    • Karol Jonscher's University Hospital
  • Rzeszów, Poland
    • Medical College of Rzeszow University
  • Warsaw, Poland
    • Children's Memorial Health Institute
• Spain
  • Almería, Spain
    • Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital
  • Granada, Spain
    • EURISTIKOS Excellence Centre for Paediatric Research, University of Granada
  • Madrid, Spain
    • Department of Neonatology, Hospital Universitario La Paz
  • Reus, Spain
    • Hospital Universitari Sant Joan de Reus
  • Tarragona, Spain
    • Hospital Universitari Joan Xxiii de Tarragona
  • Valencia, Spain
    • INCLIVA Health Research Institute
  • Zaragoza, Spain
    • Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental formula; Infant and follow-on goat milk formula	Dietary supplement: Infant formula and follow-on formula made from whole goat milk; Infant formula and follow-on formula made from whole goat milk
Active Comparator: Control formula; Infant and follow-on cow milk formula	Dietary supplement: Infant formula and follow-on formula made from cow's milk ingredients; Infant formula and follow-on formula made from cow's milk ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months	Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months diagnosed by study personnel (defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis)	Age 24 and 60 months
Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months	Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months, defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis	Age 12, 24 and 60 months
Point incidence of atopic dermatitis	Point incidence of study and parental diagnosis of atopic dermatitis, defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis at the age of 4, 6, 12, 24 and 60 months	at 4, 6, 12, 24 and 60 months of age
Time to onset of atopic dermatitis	Age at first study or reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months	Age 12, 24 and 60 months
Severity of atopic dermatitis	Atopic dermatitis severity in children with diagnosed (study diagnosis or reported diagnosis) atopic dermatitis, using the SCORing Atopic Dermatitis (SCORAD; Severity Score: 0 to 104, with a higher score indicating more severe eczema) questionnaire completed by a study nurse at all face-to-face visits at 4, 6, 12, 24 and 60 months of age.	at 4, 6, 12, 24 and 60 months of age
Severity of atopic dermatitis	Atopic dermatitis severity in children with diagnosed (study diagnosis or reported diagnosis) atopic dermatitis, using the Patient Orientated Eczema Measure (POEM; Severity Score: 0 to 28, with a higher score indicating more severe eczema) questionnaire completed by parents at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age	at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age
Cumulative use of atopic dermatitis-related medication	Cumulative use of eczema-related medication or skin care for eczema up to 12, 24 and 60 months of age	Age 12, 24 and 60 months of age
Cumulative incidence of atopic dermatitis in risk-related subgroups	Cumulative incidence of atopic dermatitis in risk-related subgroups up to 12, 24 and 60 months of age	Age 12, 24 and 60 months of age
Incidence of parental reported food allergy	Parental report of a clinical diagnosis of food allergy at 12, 24 and 60 months of age	Age 12, 24 and 60 months of age
Incidence of allergic sensitization to food or non-food allergens	Allergic sensitization at 12 and 60 months of age to any of the common allergens (specific and total IgE)	Age 12 and 60 months of age
Incidence of hay fever, asthma and asthma-related diseases	Parental reported hay fever and asthma-related diseases (wheezing and allergic rhinitis) up to 12, 24 and 60 months of age	Age 12, 24 and 60 months
Biochemical markers: blood markers	Blood: complete blood count (given numbers of different cells per volume and suitable ratios) at 4, 12 and 60 months of age	at 4, 12 and 60 months of age
Biochemical and metabolic markers: blood markers	Blood: lipidome and metabolome (including more than 300 compounds reported in µmol/liter) at 4, 12 and 60 months of age	at 4, 12 and 60 months of age
Biochemical and metabolic markers: blood markers	Blood: inflammation markers (including immunoglobulins and cytokines reported as relative units/liter and ng/ml, respectively) at 4, 12 and 60 months of age	at 4, 12 and 60 months of age
Genetic markers: blood markers	Blood: filaggrin gene at 12 months of age	at 12 months of age
Gut microbiome profile	Stool: microbiome	at 4, 12 and 60 months of age
Growth parameters	Anthropometry: weight (in kg) at baseline, 4, 6, 12, 24 and 60 months of age	at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters	Anthropometry: recumbent length (in cm) at baseline, 4, 6, 12, 24 and standard height (in cm) at 24 and 60 months of age	at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters	Anthropometry: BMI (weight and height will be combined to report BMI in kg/cm2) at baseline, 4, 6, 12, 24 and 60 months of age	at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters	Anthropometry: weight-for-age, length-for-age and BMI-for-age z-scores (WHO growth standards) at baseline, 4, 6, 12, 24 and 60 months of age	at baseline, 4, 6, 12, 24 and 60 months of age
Gastrointestinal symptoms	Parental report of gastrointestinal symptoms using the Infant Gastrointestinal Symptom Questionnaire (IGSQ; Index Score range from 13 to 65, with higher scores indicating greater gastrointestinal symptom burden) at 4, 6 and 12 months of age	at 4, 6 and 12 months of age
Sleep	Parental report of sleep using the Brief Infant Sleep Questionnaire (BISQ; data in time: hours and minutes of sleep time) at 4, 6 and 12 months of age	at 4, 6 and 12 months of age
Child's wellbeing	Parental report of quality of life in children using the Infant Toddler Quality of Life questionnaire™ (ITQOL; infant and parent item scales range from 0 to 100, with a higher score indicating better health) at 4, 12, 24 and 60 months of age	at 4, 12, 24 and 60 months of age
Nutrition	Nutrition questionnaire at 4, 6, 8, 10, 12 and 60 months of age	at age 4, 6, 8, 10, 12 and 60 months of age

Collaborators and Investigators

• Sponsor: Dairy Goat Co-operative (N.Z.) Limited
• Collaborators: Klinikum der Universität München
• Investigators: Principal Investigator: Berthold Koletzko, MD, PhD, Dr. von Hauner Children's Hospital, LMU University Hospital Munich

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): August 28, 2024
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Child Development; Atopic Dermatitis; Infant Formula; Infant Development; Healthy Term Infants
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: DGC201911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No