Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

NCT ID: NCT04599946

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2028-09-30

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.

Conditions

Dermatitis, Atopic; Eczema, Infantile; Infant Development; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental formula

Infant and follow-on goat milk formula

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Control formula

Infant and follow-on cow milk formula

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Klinikum der Universität München

UNKNOWN

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berthold Koletzko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Munich, , Germany

Wojewodzki Specjalistyczny Szpital Dzieciecy

Olsztyn, , Poland

Karol Jonscher's University Hospital

Poznan, , Poland

Medical College of Rzeszow University

Rzeszów, , Poland

Children's Memorial Health Institute

Warsaw, , Poland

Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital

Almería, , Spain

EURISTIKOS Excellence Centre for Paediatric Research, University of Granada

Granada, , Spain

Department of Neonatology, Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitari Sant Joan de Reus

Reus, , Spain

Hospital Universitari Joan XXIII de Tarragona

Tarragona, , Spain

INCLIVA Health Research Institute

Valencia, , Spain

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

Zaragoza, , Spain

Countries

Germany; Poland; Spain

References

Ferry 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.

Reference Type: DERIVED

PMID: 37055203 (View on PubMed)

Other Identifiers

DGC201911

Identifier Type: -

Identifier Source: org_study_id