Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	0 Days - 90 Days
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04599946
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dairy Goat Co-operative (N.Z.) Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Berthold Koletzko, MD, PhD
Principal Investigator Affiliation	Dr. von Hauner Children's Hospital, LMU University Hospital Munich
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Active, not recruiting
Countries	Germany, Poland, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development

Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental formula

Infant and follow-on goat milk formula

Active Comparator: Control formula

Infant and follow-on cow milk formula

Interventions

Dietary Supplement: - Infant formula and follow-on formula made from whole goat milk

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Munich, Germany

Status

Address

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

Munich, ,

Olsztyn, Poland

Status

Address

Wojewodzki Specjalistyczny Szpital Dzieciecy

Olsztyn, ,

Karol Jonscher's University Hospital, Poznań, Poland

Status

Address

Karol Jonscher's University Hospital

Poznań, ,

Medical College of Rzeszow University, Rzeszów, Poland

Status

Address

Medical College of Rzeszow University

Rzeszów, ,

Children's Memorial Health Institute, Warsaw, Poland

Status

Address

Children's Memorial Health Institute

Warsaw, ,

Almería, Spain

Status

Address

Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital

Almería, ,

Granada, Spain

Status

Address

EURISTIKOS Excellence Centre for Paediatric Research, University of Granada

Granada, ,

Madrid, Spain

Status

Address

Department of Neonatology, Hospital Universitario La Paz

Madrid, ,

Hospital Universitari Sant Joan de Reus, Reus, Spain

Status

Address

Hospital Universitari Sant Joan de Reus

Reus, ,

Tarragona, Spain

Status

Address

Hospital Universitari Joan XXIII de Tarragona

Tarragona, ,

INCLIVA Health Research Institute, Valencia, Spain

Status

Address

INCLIVA Health Research Institute

Valencia, ,

Zaragoza, Spain

Status

Address

Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon

Zaragoza, ,

Clinical Trial Finder