|- candidate number||1544|
|- NTR Number||NTR339|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||CAMEL.|
|- Scientific Title||Cow's milk Allergy Mediated by Elimination and Lactobacilli.|
|- hypothesis||Probiotic supplementation in young infants (1st 2 years of life) has a therapeutic effect, associated with upregulation of tolerance for cow's milk allergens, as well as combined with local and systemic immunomodulation and improvement of allergic manifestations in the gut, skin and airways.|
|- Healt Condition(s) or Problem(s) studied||Cow's milk allergy|
|- Inclusion criteria||1. Under 6 months of age;|
2. Documented cow's milk allergy, judged by an elimination-challenge test (open) and re-elimination, in conformity with the guidelines of ESPGHAN (European Society for Pediatric Gastroenterology, Hepatology and Nutrition);
3. Informed consent by the parents/care-takers.
|- Exclusion criteria||1. Breast-feeding during the study;|
2. Age > 6 months;
3. Chronic diseases, which may be relevant for this study, such as pre-existing chest abnormalities (e.g. BPD and relevant congenital abnormalities), gastro-intestinal diseases (celiac disease, enzyme disorders) and metabolic diseases;
4. Prematurity; < 32 weeks;
5. Congenital abnormalities, which may be relevant for this study;
6. Use of systemic drugs for allergy (corticosteroids and antihistamines).
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2003|
|- planned closingdate||1-jan-2008|
|- Target number of participants||200|
|- Interventions||In children with cow's milk allergy diagnosed by an elimination-challenge test (open), the longitudinal development will be followed from inclusion (< age 6 months) during 18 months.|
All participants will recieve a hydrolysed formula (caseïne hydrolysate, Allergycare®, Friesland Foods).
2 probiotic strains (one lactobacillus and one bifidobacteria) will be added to the Allergycare® in 50% of the participants, as intervention for 12 months, randomised, double-blind.
|- Primary outcome||Development of tolerance for cow's milk, observed by a challenge test (double blind) after 12 months of treatment. |
|- Secondary outcome||1. The severity of cow milk allergy related features, namely variables onf physical inspection, as well as observed features by the parents in a questionnaire/diary;|
2. Assessment of skin features will be performed by the objective SCORAD, as a measure for the severity of atopic dermatitis;
3. Need for medication;
4. Quality of life, as judged by the parents and noted in a questionnaire/diary;
5. Weight and height;
6. Effects on immuno(dys)regulation; on sensibilisation, namely allergen-specific IgE and epitope-specific IgE, T-lymfocyte subsets, as measured by membrane markers, signal-transduction proteins related to immunomodulation, In-vitro allergen–stimulated T-lymphocyte activity with specific cytokine detection.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. Jeroen Hol|
|- CONTACT for SCIENTIFIC QUERIES||MD. Jeroen Hol|
|- Sponsor/Initiator ||Friesland Foods|
(Source(s) of Monetary or Material Support)
|- Brief summary||In a group of young children with early manifestation of allergic disease, namely cow’s milk allergy, the course of cow’s milk allergy, as well as other allergic manifestations, and the development of the immune system will be followed prospectively. |
Children under the age of 6 months with cow's milk allergy will be included in this intervention study. Intervention will be performed using probiotics, double blind centrally randomised, in 50 % of the participants during a period of 12 months, which will be administered to a standard hydrolysed formula for all participants.
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 9-dec-2010|
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