Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

Child Development Clinical Trial

— GIraFFE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04599946
• Other study ID #: DGC201911
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: September 2028

Study information

• Verified date: October 2023
• Source: Dairy Goat Co-operative (N.Z.) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2132
• Est. completion date: September 2028
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eczema, Infantile
• Infant Development

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dairy Goat Co-operative (N.Z.) Limited	Klinikum der Universität München

Countries where clinical trial is conducted

Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Genetic markers: blood markers	Blood: filaggrin gene at 12 months of age	at 12 months of age
Secondary	Gut microbiome profile	Stool: microbiome	at 4, 12 and 60 months of age
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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