Effects of Infant Feeding with Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis

Who is this study for? Infant patients with Atopic Dermatitis
What treatments are being studied? Milk Formula
Status: Active_not_recruiting
Location: See all (12) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 months
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Germany
Dr. von Hauner Children's Hospital, LMU University Hospital Munich
Munich
Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy
Olsztyn
Karol Jonscher's University Hospital
Poznan
Medical College of Rzeszow University
Rzeszów
Children's Memorial Health Institute
Warsaw
Spain
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
Time Frame
Start Date: 2021-01-08
Completion Date: 2028-09
Participants
Target number of participants: 2132
Treatments
Experimental: Experimental formula
Infant and follow-on goat milk formula
Active_comparator: Control formula
Infant and follow-on cow milk formula
Related Therapeutic Areas
Sponsors
Leads: Dairy Goat Co-operative (N.Z.) Limited
Collaborators: Klinikum der Universität München

This content was sourced from clinicaltrials.gov