CAMEL: Cow's milk Allergy Mediated by Elimination and Lactobacilli

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2005
INTERVENTION: In children with cow's milk allergy diagnosed by an elimination‐challenge test (open), the longitudinal development will be followed from inclusion (less than age 6 months) during 18 months. All participants will receive a hydrolysed formula (caseïne hydrolysate, Allergycare®, Friesland Foods). Two 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. CONDITION: Allergy to cow's milk ; Injury, Occupational Diseases, Poisoning ; Adverse effects, not elsewhere classified 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 on 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 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
Epistemonikos ID: e3f4b86a4fe20dfa2310b1814cfcb0f17286e944
First added on: Aug 21, 2024