dc.contributor.author
Kalb, Birgit
dc.contributor.author
Meixner, Lara
dc.contributor.author
Trendelenburg, Valérie
dc.contributor.author
Unterleider, Nathalie
dc.contributor.author
Dobbertin-Welsch, Josefine
dc.contributor.author
Heller, Stephanie
dc.contributor.author
Dölle-Bierke, Sabine
dc.contributor.author
Roll, Stephanie
dc.contributor.author
Lau, Susanne
dc.contributor.author
Lee, Young-Ae
dc.contributor.author
Fauchère, Florent
dc.contributor.author
Braun, Julian
dc.contributor.author
Babina, Magda
dc.contributor.author
Altrichter, Sabine
dc.contributor.author
Birkner, Till
dc.contributor.author
Worm, Margitta
dc.contributor.author
Beyer, Kirsten
dc.date.accessioned
2024-03-21T13:30:55Z
dc.date.available
2024-03-21T13:30:55Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/42972
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-42686
dc.description.abstract
Background: Up to 8% of all children in industrialized countries suffer from food allergies, whereas children with atopic eczema are affected considerably more frequently. In addition, the type and starting time of weaning foods seem to influence the development of food allergies. However, data from interventional studies on weaning are controversial. The aim of this randomized-controlled clinical trial is to investigate, whether an early introduction of hen's egg (HE), cow's milk (CM), peanut (PN), and hazelnut (HN) in children with atopic eczema can reduce the risk for developing food allergies in the first year of life.
Methods: This is a protocol for a randomized, placebo controlled, double blind, single-center clinical trial. One hundred fifty infants with atopic eczema at 4-8 months of age will be randomized in a 2:1 manner into an active group that will receive rusk-like biscuit powder with HE, CM, PN, and HN (initially approximately 2 mg of each food protein) for 6-8 months or a placebo group, whose participants will receive the same rusk-like biscuit powder without HE, CM, PN, and HN on a daily basis. During the interventional period, the amount of allergens in the study product will be increased three times, each after 6 weeks. All study participants who are sensitized to HE, CM, PN, or HN at the end of the interventional period will undergo an oral food challenge to the respective food in a further visit. Primary endpoint is IgE-mediated food allergy to at least one of the four foods (HE, CM, PN or HN) after 6-8 months of intervention (i.e., at around 1 year of age). Secondary endpoints include multiple food allergies, severity of eczema, wheezing, and sensitization levels against food allergens.
Discussion: This clinical trial will assess whether an early introduction of allergenic foods into the diet of children with atopic eczema can prevent the development of food allergies. This trial will contribute to update food allergy prevention guidelines.
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject
Randomized controlled trial
en
dc.subject
Food allergy
en
dc.subject
Atopic dermatitis
en
dc.subject
Early feeding
en
dc.subject
Weaning foods
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
Tolerance induction through early feeding to prevent food allergy in infants with eczema (TEFFA): rationale, study design, and methods of a randomized controlled trial
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.articlenumber
210
dcterms.bibliographicCitation.doi
10.1186/s13063-022-06126-x
dcterms.bibliographicCitation.journaltitle
Trials
dcterms.bibliographicCitation.number
1
dcterms.bibliographicCitation.originalpublishername
Springer Nature
dcterms.bibliographicCitation.volume
23
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.funding
Springer Nature DEAL
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
35279213
dcterms.isPartOf.eissn
1745-6215