Dermatitis, AtopicGIraFFENCT04599946
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
A study testing Infant formula and follow-on formula made from whole goat milk and Infant formula and follow-on formula made from cow's milk ingredients in people with Dermatitis, Atopic and Eczema, Infantile, run by Dairy Goat Co-operative (N.Z.) Limited at 12 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic, Eczema, Infantile, Infant Development
- What is being tested?
- Infant formula and follow-on formula made from whole goat milk and Infant formula and follow-on formula made from cow's milk ingredients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,132 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 8 Jan 2021to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Spain7 sites
Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital
Almería
EURISTIKOS Excellence Centre for Paediatric Research, University of Granada
Granada
Department of Neonatology, Hospital Universitario La Paz
Madrid
Hospital Universitari Sant Joan de Reus
Reus
Hospital Universitari Joan XXIII de Tarragona
Tarragona
INCLIVA Health Research Institute
Valencia
Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon
Zaragoza
Poland4 sites
Wojewodzki Specjalistyczny Szpital Dzieciecy
Olsztyn
Karol Jonscher's University Hospital
Poznan
Medical College of Rzeszow University
Rzeszów
Children's Memorial Health Institute
Warsaw
Germany1 site
Dr. von Hauner Children's Hospital, LMU University Hospital Munich
Munich
About this study
Official title: Effects of Infant Feeding With Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis
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.
Read the 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.
- Being tested
- Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
- Keywords
- Atopic Dermatitis, Healthy Term Infants, Infant Formula, Infant Development, Child Development
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula and follow-on formula made from whole goat milkDietary supplement
Infant formula and follow-on formula made from whole goat milk
Infant formula and follow-on formula made from cow's milk ingredientsDietary supplement
Infant formula and follow-on formula made from cow's milk ingredients
| Study group | Role | What they receive |
|---|---|---|
| Experimental formula | Experimental | Infant and follow-on goat milk formula Receives: Dietary Supplement: Infant formula and follow-on formula made from whole goat milk |
| Control formula | Active comparator | Infant and follow-on cow milk formula Receives: Dietary Supplement: Infant formula and follow-on formula made from cow's milk ingredients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Age 12 months
Secondary outcomes (24)
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)
Measured: Age 24 and 60 months
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
Measured: Age 12, 24 and 60 months
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
Measured: at 4, 6, 12, 24 and 60 months of age
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
Measured: Age 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.
Measured: 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
Measured: 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
Measured: Age 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
Measured: Age 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
Measured: Age 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)
Measured: Age 12 and 60 months of age
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
Measured: Age 12, 24 and 60 months
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
Measured: 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
Measured: 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
Measured: at 4, 12 and 60 months of age
Genetic markers: blood markers
Blood: filaggrin gene at 12 months of age
Measured: at 12 months of age
Gut microbiome profile
Stool: microbiome
Measured: at 4, 12 and 60 months of age
Growth parameters
Anthropometry: weight (in kg) at baseline, 4, 6, 12, 24 and 60 months of age
Measured: 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
Measured: at baseline, 4, 6, 12, 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 4, 12, 24 and 60 months of age
Nutrition
Nutrition questionnaire at 4, 6, 8, 10, 12 and 60 months of age
Measured: at age 4, 6, 8, 10, 12 and 60 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start8 Jan 2021
- Primary completion28 Aug 2024
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dairy Goat Co-operative (N.Z.) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LMU Klinikum
- Responsible party
- Sponsor
- Investigators
- Berthold Koletzko, MD, PhD, Principal investigator, Dr. von Hauner Children's Hospital, LMU University Hospital Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599946
- Sponsor's protocol ID
- DGC201911
- Acronym
- GIraFFE
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2020
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grote V, Schlosser L, Campoy C, Crehua-Gaudiza E, Demmelmair H, Ege MJ, Escribano J, Galera-Martinez R, Garcia-Santos JA, Gruszfeld D, Guerlich K, Guillen-Sebastian C, Handel U, Jamka M, Jarocka-Cyrta E, Ksiazyk J, Mazur A, Parada-Ricart E, Robredo-Garcia I, Rodriguez G, Romanczuk B, Saenz de Pipaon M, Tejon-Fernandez M, Walkowiak J, Weichselbaum E, Witte A, Koletzko B. Whole goat milk versus cow milk formula and atopic dermatitis in infants: A randomized clinical trial. Clin Nutr. 2026 Aug;63:106707. doi: 10.1016/j.clnu.2026.106707. Epub 2026 Jun 3.
PubMed 42275985Ferry JM, Galera-Martinez R, Campoy C, Saenz de Pipaon M, Jarocka-Cyrta E, Walkowiak J, Romanczuk B, Escribano J, Gispert M, Grattarola P, Gruszfeld D, Iglesia I, Grote V, Demmelmair H, Handel U, Gallier S, Koletzko B. Effects of infant feeding with goat milk formula or cow milk formula on atopic dermatitis: protocol of the randomised controlled Goat Infant Formula Feeding and Eczema (GIraFFE) trial. BMJ Open. 2023 Apr 13;13(4):e070533. doi: 10.1136/bmjopen-2022-070533.
PubMed 37055203
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infant Feeding With Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04599946
- Acronym / sponsor ID
- GIraFFE / DGC201911
- Keywords
- Atopic Dermatitis, Healthy Term Infants, Infant Formula, Infant Development, Child Development
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,132 participants (actual)
- Lead sponsor
- Dairy Goat Co-operative (N.Z.) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- LMU Klinikum
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental formula | Experimental | Dietary Supplement: Infant formula and follow-on formula made from whole goat milkInfant and follow-on goat milk formula |
| Control formula | Active comparator | Dietary Supplement: Infant formula and follow-on formula made from cow's milk ingredientsInfant and follow-on cow milk formula |
Who may qualify
- Ages
- 0 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formula and follow-on formula made from whole goat milkInfant formula and follow-on formula made from whole goat milk | Dietary supplement | Experimental formula |
| Infant formula and follow-on formula made from cow's milk ingredientsInfant formula and follow-on formula made from cow's milk ingredients | Dietary supplement | Control formula |
Primary outcome
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)
24 secondary outcomes
Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months
Time frame: Age 24 and 60 months
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
Point incidence of atopic dermatitis
Time frame: at 4, 6, 12, 24 and 60 months of age
Time to onset of atopic dermatitis
Time frame: Age 12, 24 and 60 months
Severity of atopic dermatitis
Time frame: at 4, 6, 12, 24 and 60 months of age
Severity of atopic dermatitis
Time frame: at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age
Cumulative use of atopic dermatitis-related medication
Time frame: Age 12, 24 and 60 months of age
Cumulative incidence of atopic dermatitis in risk-related subgroups
Time frame: Age 12, 24 and 60 months of age
Incidence of parental reported food allergy
Time frame: Age 12, 24 and 60 months of age
Incidence of allergic sensitization to food or non-food allergens
Time frame: Age 12 and 60 months of age
Incidence of hay fever, asthma and asthma-related diseases
Time frame: Age 12, 24 and 60 months
Biochemical markers: blood markers
Time frame: at 4, 12 and 60 months of age
Biochemical and metabolic markers: blood markers
Time frame: at 4, 12 and 60 months of age
Biochemical and metabolic markers: blood markers
Time frame: at 4, 12 and 60 months of age
Genetic markers: blood markers
Time frame: at 12 months of age
Gut microbiome profile
Time frame: at 4, 12 and 60 months of age
Growth parameters
Time frame: at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters
Time frame: at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters
Time frame: at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters
Time frame: at baseline, 4, 6, 12, 24 and 60 months of age
Gastrointestinal symptoms
Time frame: at 4, 6 and 12 months of age
Sleep
Time frame: at 4, 6 and 12 months of age
Child's wellbeing
Time frame: at 4, 12, 24 and 60 months of age
Nutrition
Time frame: at age 4, 6, 8, 10, 12 and 60 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 42275985Grote V, Schlosser L, Campoy C, Crehua-Gaudiza E, Demmelmair H, Ege MJ, Escribano J, Galera-Martinez R, Garcia-Santos JA, Gruszfeld D, Guerlich K, Guillen-Sebastian C, Handel U, Jamka M, Jarocka-Cyrta E, Ksiazyk J, Mazur A, Parada-Ricart E, Robredo-Garcia I, Rodriguez G, Romanczuk B, Saenz de Pipaon M, Tejon-Fernandez M, Walkowiak J, Weichselbaum E, Witte A, Koletzko B. Whole goat milk versus cow milk formula and atopic dermatitis in infants: A randomized clinical trial. Clin Nutr. 2026 Aug;63:106707. doi: 10.1016/j.clnu.2026.106707. Epub 2026 Jun 3.
- Derived from this study: PubMed 37055203Ferry JM, Galera-Martinez R, Campoy C, Saenz de Pipaon M, Jarocka-Cyrta E, Walkowiak J, Romanczuk B, Escribano J, Gispert M, Grattarola P, Gruszfeld D, Iglesia I, Grote V, Demmelmair H, Handel U, Gallier S, Koletzko B. Effects of infant feeding with goat milk formula or cow milk formula on atopic dermatitis: protocol of the randomised controlled Goat Infant Formula Feeding and Eczema (GIraFFE) trial. BMJ Open. 2023 Apr 13;13(4):e070533. doi: 10.1136/bmjopen-2022-070533.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Koletzko, MD, PhD principal investigator
Dr. von Hauner Children's Hospital, LMU University Hospital Munich
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula and follow-on formula made from whole goat milk and Infant formula and follow-on formula made from cow's milk ingredients in people with Dermatitis, Atopic and Eczema, Infantile, run by Dairy Goat Co-operative (N.Z.) Limited at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of atopic dermatitis up to the age of 12 months (time frame: Age 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04599946, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.