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Active, Not Recruiting

NCT Number: NCT04599946

Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dermatitis, Atopic Child Development Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Eczema, Infantile Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant Development Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

0 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. von Hauner Children's Hospital, LMU University Hospital Munich, Munich, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant formula and follow-on formula made from whole goat milk

Dietary Supplement

Infant formula and follow-on formula made from whole goat milk

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

Dietary Supplement

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

Primary outcomes

  1. Cumulative incidence of atopic dermatitis up to the age of 12 months

    Time frame: Age 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)

Secondary outcomes

  1. Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months

    Time frame: Age 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)

  2. Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months

    Time frame: Age 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

  3. Point incidence of atopic dermatitis

    Time frame: at 4, 6, 12, 24 and 60 months of age

    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

  4. Time to onset of atopic dermatitis

    Time frame: Age 12, 24 and 60 months

    Age at first study or reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months

  5. Severity of atopic dermatitis

    Time frame: at 4, 6, 12, 24 and 60 months of age

    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.

  6. Severity of atopic dermatitis

    Time frame: at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age

    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

  7. Cumulative use of atopic dermatitis-related medication

    Time frame: Age 12, 24 and 60 months of age

    Cumulative use of eczema-related medication or skin care for eczema up to 12, 24 and 60 months of age

  8. Cumulative incidence of atopic dermatitis in risk-related subgroups

    Time frame: Age 12, 24 and 60 months of age

    Cumulative incidence of atopic dermatitis in risk-related subgroups up to 12, 24 and 60 months of age

  9. Incidence of parental reported food allergy

    Time frame: Age 12, 24 and 60 months of age

    Parental report of a clinical diagnosis of food allergy at 12, 24 and 60 months of age

  10. Incidence of allergic sensitization to food or non-food allergens

    Time frame: Age 12 and 60 months of age

    Allergic sensitization at 12 and 60 months of age to any of the common allergens (specific and total IgE)

  11. Incidence of hay fever, asthma and asthma-related diseases

    Time frame: Age 12, 24 and 60 months

    Parental reported hay fever and asthma-related diseases (wheezing and allergic rhinitis) up to 12, 24 and 60 months of age

  12. Biochemical markers: blood markers

    Time frame: at 4, 12 and 60 months of age

    Blood: complete blood count (given numbers of different cells per volume and suitable ratios) at 4, 12 and 60 months of age

  13. Biochemical and metabolic markers: blood markers

    Time frame: at 4, 12 and 60 months of age

    Blood: lipidome and metabolome (including more than 300 compounds reported in µmol/liter) at 4, 12 and 60 months of age

  14. Biochemical and metabolic markers: blood markers

    Time frame: at 4, 12 and 60 months of age

    Blood: inflammation markers (including immunoglobulins and cytokines reported as relative units/liter and ng/ml, respectively) at 4, 12 and 60 months of age

  15. Genetic markers: blood markers

    Time frame: at 12 months of age

    Blood: filaggrin gene at 12 months of age

  16. Gut microbiome profile

    Time frame: at 4, 12 and 60 months of age

    Stool: microbiome

  17. Growth parameters

    Time frame: at baseline, 4, 6, 12, 24 and 60 months of age

    Anthropometry: weight (in kg) at baseline, 4, 6, 12, 24 and 60 months of age

  18. Growth parameters

    Time frame: at baseline, 4, 6, 12, 24 and 60 months of age

    Anthropometry: recumbent length (in cm) at baseline, 4, 6, 12, 24 and standard height (in cm) at 24 and 60 months of age

  19. Growth parameters

    Time frame: at baseline, 4, 6, 12, 24 and 60 months of age

    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

  20. Growth parameters

    Time frame: at baseline, 4, 6, 12, 24 and 60 months of age

    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

  21. Gastrointestinal symptoms

    Time frame: at 4, 6 and 12 months of age

    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

  22. Sleep

    Time frame: at 4, 6 and 12 months of age

    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

  23. Child's wellbeing

    Time frame: at 4, 12, 24 and 60 months of age

    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

  24. Nutrition

    Time frame: at age 4, 6, 8, 10, 12 and 60 months of age

    Nutrition questionnaire at 4, 6, 8, 10, 12 and 60 months of age

Sponsors and collaborators

Lead sponsor

Dairy Goat Co-operative (N.Z.) Limited

Industry

Collaborators

  • Klinikum der Universität München

Registry information

Official study title

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

Acronym: GIraFFE

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Oct 23, 2020
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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