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Goat Infant Formula Feeding and Eczema (the GIraFFE Study) (GIraFFE)

Primary Purpose

Dermatitis, Atopic, Eczema, Infantile, Infant Development

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Infant formula and follow-on formula made from whole goat milk
Infant formula and follow-on formula made from cow's milk ingredients
Sponsored by
Dairy Goat Co-operative (N.Z.) Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dermatitis, Atopic focused on measuring Atopic Dermatitis, Healthy Term Infants, Infant Formula, Infant Development, Child Development

Eligibility Criteria

0 Days - 90 Days (Child)All SexesAccepts 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

Sites / Locations

  • Dr. von Hauner Children's Hospital, LMU University Hospital Munich
  • Wojewodzki Specjalistyczny Szpital Dzieciecy
  • Karol Jonscher's University Hospital
  • Medical College of Rzeszow University
  • Children's Memorial Health Institute
  • Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital
  • EURISTIKOS Excellence Centre for Paediatric Research, University of Granada
  • Department of Neonatology, Hospital Universitario La Paz
  • Hospital Universitari Sant Joan de Reus
  • Hospital Universitari Joan XXIII de Tarragona
  • INCLIVA Health Research Institute
  • Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental formula

Control formula

Arm Description

Infant and follow-on goat milk formula

Infant and follow-on cow milk formula

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
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
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
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.
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
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
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
Incidence of parental reported food allergy
Parental report of a clinical diagnosis of food allergy at 12, 24 and 60 months of age
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)
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
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
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
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
Genetic markers: blood markers
Blood: filaggrin gene at 12 months of age
Gut microbiome profile
Stool: microbiome
Growth parameters
Anthropometry: weight (in kg) at baseline, 4, 6, 12, 24 and 60 months of age
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
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
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
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
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
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
Nutrition
Nutrition questionnaire at 4, 6, 8, 10, 12 and 60 months of age

Full Information

First Posted
October 5, 2020
Last Updated
October 16, 2023
Sponsor
Dairy Goat Co-operative (N.Z.) Limited
Collaborators
Klinikum der Universität München
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1. Study Identification

Unique Protocol Identification Number
NCT04599946
Brief Title
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
Acronym
GIraFFE
Official Title
Effects of Infant Feeding With Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dairy Goat Co-operative (N.Z.) Limited
Collaborators
Klinikum der Universität München

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development
Keywords
Atopic Dermatitis, Healthy Term Infants, Infant Formula, Infant Development, Child Development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadrupole
Allocation
Randomized
Enrollment
2132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental formula
Arm Type
Experimental
Arm Description
Infant and follow-on goat milk formula
Arm Title
Control formula
Arm Type
Active Comparator
Arm Description
Infant and follow-on cow milk formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Infant formula and follow-on formula made from whole goat milk
Intervention Description
Infant formula and follow-on formula made from whole goat milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Infant formula and follow-on formula made from cow's milk ingredients
Intervention Description
Infant formula and follow-on formula made from cow's milk ingredients
Primary Outcome Measure Information:
Title
Cumulative incidence of atopic dermatitis up to the age of 12 months
Description
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)
Time Frame
Age 12 months
Secondary Outcome Measure Information:
Title
Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months
Description
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)
Time Frame
Age 24 and 60 months
Title
Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months
Description
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
Time Frame
Age 12, 24 and 60 months
Title
Point incidence of atopic dermatitis
Description
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
Time Frame
at 4, 6, 12, 24 and 60 months of age
Title
Time to onset of atopic dermatitis
Description
Age at first study or reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months
Time Frame
Age 12, 24 and 60 months
Title
Severity of atopic dermatitis
Description
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.
Time Frame
at 4, 6, 12, 24 and 60 months of age
Title
Severity of atopic dermatitis
Description
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
Time Frame
at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age
Title
Cumulative use of atopic dermatitis-related medication
Description
Cumulative use of eczema-related medication or skin care for eczema up to 12, 24 and 60 months of age
Time Frame
Age 12, 24 and 60 months of age
Title
Cumulative incidence of atopic dermatitis in risk-related subgroups
Description
Cumulative incidence of atopic dermatitis in risk-related subgroups up to 12, 24 and 60 months of age
Time Frame
Age 12, 24 and 60 months of age
Title
Incidence of parental reported food allergy
Description
Parental report of a clinical diagnosis of food allergy at 12, 24 and 60 months of age
Time Frame
Age 12, 24 and 60 months of age
Title
Incidence of allergic sensitization to food or non-food allergens
Description
Allergic sensitization at 12 and 60 months of age to any of the common allergens (specific and total IgE)
Time Frame
Age 12 and 60 months of age
Title
Incidence of hay fever, asthma and asthma-related diseases
Description
Parental reported hay fever and asthma-related diseases (wheezing and allergic rhinitis) up to 12, 24 and 60 months of age
Time Frame
Age 12, 24 and 60 months
Title
Biochemical markers: blood markers
Description
Blood: complete blood count (given numbers of different cells per volume and suitable ratios) at 4, 12 and 60 months of age
Time Frame
at 4, 12 and 60 months of age
Title
Biochemical and metabolic markers: blood markers
Description
Blood: lipidome and metabolome (including more than 300 compounds reported in µmol/liter) at 4, 12 and 60 months of age
Time Frame
at 4, 12 and 60 months of age
Title
Biochemical and metabolic markers: blood markers
Description
Blood: inflammation markers (including immunoglobulins and cytokines reported as relative units/liter and ng/ml, respectively) at 4, 12 and 60 months of age
Time Frame
at 4, 12 and 60 months of age
Title
Genetic markers: blood markers
Description
Blood: filaggrin gene at 12 months of age
Time Frame
at 12 months of age
Title
Gut microbiome profile
Description
Stool: microbiome
Time Frame
at 4, 12 and 60 months of age
Title
Growth parameters
Description
Anthropometry: weight (in kg) at baseline, 4, 6, 12, 24 and 60 months of age
Time Frame
at baseline, 4, 6, 12, 24 and 60 months of age
Title
Growth parameters
Description
Anthropometry: recumbent length (in cm) at baseline, 4, 6, 12, 24 and standard height (in cm) at 24 and 60 months of age
Time Frame
at baseline, 4, 6, 12, 24 and 60 months of age
Title
Growth parameters
Description
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
Time Frame
at baseline, 4, 6, 12, 24 and 60 months of age
Title
Growth parameters
Description
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
Time Frame
at baseline, 4, 6, 12, 24 and 60 months of age
Title
Gastrointestinal symptoms
Description
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
Time Frame
at 4, 6 and 12 months of age
Title
Sleep
Description
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
Time Frame
at 4, 6 and 12 months of age
Title
Child's wellbeing
Description
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
Time Frame
at 4, 12, 24 and 60 months of age
Title
Nutrition
Description
Nutrition questionnaire at 4, 6, 8, 10, 12 and 60 months of age
Time Frame
at age 4, 6, 8, 10, 12 and 60 months of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Koletzko, MD, PhD
Organizational Affiliation
Dr. von Hauner Children's Hospital, LMU University Hospital Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. von Hauner Children's Hospital, LMU University Hospital Munich
City
Munich
Country
Germany
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy
City
Olsztyn
Country
Poland
Facility Name
Karol Jonscher's University Hospital
City
Poznań
Country
Poland
Facility Name
Medical College of Rzeszow University
City
Rzeszów
Country
Poland
Facility Name
Children's Memorial Health Institute
City
Warsaw
Country
Poland
Facility Name
Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital
City
Almería
Country
Spain
Facility Name
EURISTIKOS Excellence Centre for Paediatric Research, University of Granada
City
Granada
Country
Spain
Facility Name
Department of Neonatology, Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitari Sant Joan de Reus
City
Reus
Country
Spain
Facility Name
Hospital Universitari Joan XXIII de Tarragona
City
Tarragona
Country
Spain
Facility Name
INCLIVA Health Research Institute
City
Valencia
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

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