Clinical trial NCT04599946: Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
Official title: Effects of Infant Feeding with Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dermatitis, Atopic
Eczema, Infantile
Infant Development
Child Development
Keywords: Atopic Dermatitis
Healthy Term Infants
Infant Formula
Infant Development
Child Development
Lead sponsor: Dairy Goat Co-operative (N.Z.) Limited
Sponsor class: INDUSTRY
Collaborators: name: Klinikum der Universität München
First posted: 2020-10-23
Enrollment: 2132
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of atopic dermatitis up to the age of 12 months
timeFrame: Age 12 months
Secondary outcomes:
measure: Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months
timeFrame: Age 24 and 60 months
measure: Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months
timeFrame: Age 12, 24 and 60 months
measure: Point incidence of atopic dermatitis
timeFrame: at 4, 6, 12, 24 and 60 months of age
measure: Time to onset of atopic dermatitis
timeFrame: Age 12, 24 and 60 months
measure: Severity of atopic dermatitis
timeFrame: at 4, 6, 12, 24 and 60 months of age
measure: Severity of atopic dermatitis
timeFrame: at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age
measure: Cumulative use of atopic dermatitis-related medication
timeFrame: Age 12, 24 and 60 months of age
measure: Cumulative incidence of atopic dermatitis in risk-related subgroups
timeFrame: Age 12, 24 and 60 months of age
measure: Incidence of parental reported food allergy
timeFrame: Age 12, 24 and 60 months of age
measure: Incidence of allergic sensitization to food or non-food allergens
timeFrame: Age 12 and 60 months of age
measure: Incidence of hay fever, asthma and asthma-related diseases
timeFrame: Age 12, 24 and 60 months
measure: Biochemical markers: blood markers
timeFrame: at 4, 12 and 60 months of age
measure: Biochemical and metabolic markers: blood markers
timeFrame: at 4, 12 and 60 months of age
measure: Biochemical and metabolic markers: blood markers
timeFrame: at 4, 12 and 60 months of age
measure: Genetic markers: blood markers
timeFrame: at 12 months of age
measure: Gut microbiome profile
timeFrame: at 4, 12 and 60 months of age
measure: Growth parameters
timeFrame: at baseline, 4, 6, 12, 24 and 60 months of age
measure: Growth parameters
timeFrame: at baseline, 4, 6, 12, 24 and 60 months of age
measure: Growth parameters
timeFrame: at baseline, 4, 6, 12, 24 and 60 months of age
measure: Growth parameters
timeFrame: at baseline, 4, 6, 12, 24 and 60 months of age
measure: Gastrointestinal symptoms
timeFrame: at 4, 6 and 12 months of age
measure: Sleep
timeFrame: at 4, 6 and 12 months of age
measure: Child's wellbeing
timeFrame: at 4, 12, 24 and 60 months of age
measure: Nutrition
timeFrame: at age 4, 6, 8, 10, 12 and 60 months of age
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dr. von Hauner Children's Hospital, LMU University Hospital Munich
city: Olsztyn
country: Poland
facility: Wojewodzki Specjalistyczny Szpital Dzieciecy
city: Poznań
country: Poland
facility: Karol Jonscher's University Hospital
city: Rzeszów
country: Poland
facility: Medical College of Rzeszow University
city: Warsaw
country: Poland
facility: Children's Memorial Health Institute
city: Almería
country: Spain
facility: Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital
city: Granada
country: Spain
facility: EURISTIKOS Excellence Centre for Paediatric Research, University of Granada
city: Madrid
country: Spain
facility: Department of Neonatology, Hospital Universitario La Paz
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII de Tarragona
city: Valencia
country: Spain
facility: INCLIVA Health Research Institute
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon
Study officials:
affiliation: Dr. von Hauner Children's Hospital, LMU University Hospital Munich
name: Berthold Koletzko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: