Non-IgE mediated cow's milk allergy Niet-Ige gemedieerde koemelkallergie
Conditions
Interventions
Treatment with an extensively hydrolyzed whey based formula (eHF
Nutrilon Pepti) is compared to treatment with an amino acid-based formula (AAF
Neocate® Syneo).
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: - Infants ≤12 months of age. - Suspected non-IgE mediated CMA¡¯ as defined by a symptom score of at least 15 points and the pediatrician¡¯s opinion of a possible benefit from an elimination diet. - Symptoms are suspected to be related to cow's milk ingestion and not explained otherwise.
Exclusion criteria
Exclusion criteria: - Infants born <37 weeks gestation who require specific premature formula at time of study entry. - Infants less than 2500 g at birth. - Use of any hypoallergenic formulas (partially hydrolysed formula, eHF and/or AAF), <4 weeks prior to the first study visit, more than 1 bottle per week. - An alternative diagnosis that is more probable than non-IgE mediated CMA (as decided by the expert team). - Evidence of ¡°severe concurrent illness¡± (as specified in protocol). - The use of medication (as further specified in protocol) <4 weeks prior to the first study visit. - Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study formulas.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Time to symptom resolution - Grade of symptom resolution | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time point of acquired tolerance to cow's milk - Characteristics of children needed to switch from eHF to AAF - Explorative: immunology markers, microbiome analysis | — |
Contacts
Public ContactM.M. Vanderschuren
Wilhelmina Childrens Hospital, University Medical Center Utrecht
Outcome results
None listed