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

August 25, 2026 updated by: Dairy Goat Co-operative (N.Z.) Limited

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental formula
Infant and follow-on goat milk formula
Dietary supplement: Infant formula and follow-on formula made from whole goat milk
Infant formula and follow-on formula made from whole goat milk
Active Comparator: Control formula
Infant and follow-on cow milk formula
Dietary supplement: Infant formula and follow-on formula made from cow's milk ingredients
Infant formula and follow-on formula made from cow's milk ingredients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Age 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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
Age 12, 24 and 60 months
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
at 4, 6, 12, 24 and 60 months of age
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
Age 12, 24 and 60 months
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.
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
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
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 use of eczema-related medication or skin care for eczema up to 12, 24 and 60 months of age
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
Cumulative incidence of atopic dermatitis in risk-related subgroups up to 12, 24 and 60 months of age
Age 12, 24 and 60 months of age
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
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
Allergic sensitization at 12 and 60 months of age to any of the common allergens (specific and total IgE)
Age 12 and 60 months of age
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
Age 12, 24 and 60 months
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
at 4, 12 and 60 months of age
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
at 4, 12 and 60 months of age
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
at 4, 12 and 60 months of age
Genetic markers: blood markers
Time Frame: at 12 months of age
Blood: filaggrin gene at 12 months of age
at 12 months of age
Gut microbiome profile
Time Frame: at 4, 12 and 60 months of age
Stool: microbiome
at 4, 12 and 60 months of age
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
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
Anthropometry: recumbent length (in cm) at baseline, 4, 6, 12, 24 and standard height (in cm) at 24 and 60 months of age
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
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
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
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
at baseline, 4, 6, 12, 24 and 60 months of age
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
at 4, 6 and 12 months of age
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
at 4, 6 and 12 months of age
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
at 4, 12, 24 and 60 months of age
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
at age 4, 6, 8, 10, 12 and 60 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dairy Goat Co-operative (N.Z.) Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LMU Klinikum

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Berthold Koletzko, MD, PhD, Dr. von Hauner Children's Hospital, LMU University Hospital Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DGC201911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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