Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

  • STATUS
    Recruiting
  • End date
    Jan 26, 2028
  • participants needed
    2296
  • sponsor
    Dairy Goat Co-operative (N.Z.) Limited
Updated on 26 September 2021
eczema

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.

Details
Condition Dermatitis, Atopic, Eczéma (Dermatite Atopique), Atopic Dermatitis, Dermatite Atopique, ATOPIC DERMATITIS, Child Development, Eczema (Atopic Dermatitis)
Treatment Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
Clinical Study IdentifierNCT04599946
SponsorDairy Goat Co-operative (N.Z.) Limited
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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