Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

Dairy Goat Co-operative

Status: Active, not recruiting

Conditions: Dermatitis, Atopic; Child Development; Eczema, Infantile; Infant Development

Treatments: 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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04599946

DGC201911

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,132 patients

Sex: All

Ages: Under 90 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,132 participants in 2 patient groups

Experimental formula

Experimental group

Description:

Infant and follow-on goat milk formula

Treatment:

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

Control formula

Active Comparator group

Description:

Infant and follow-on cow milk formula

Treatment:

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