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

Not Applicable

Completed

• Conditions: Allergy to cow's milk; Injury, Occupational Diseases, Poisoning; Adverse effects, not elsewhere classified

• Registration Number: ISRCTN04799749
• Lead Sponsor: Friesland Foods (Netherlands)

Brief Summary

2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18436293 (added 14/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2008-01-01
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

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. Aged greater than 6 months
3. Chronic diseases, which may be relevant for this study, such as pre-existing chest abnormalities (e.g. broncho-pulmonary dysplasia [BPD] and relevant congenital abnormalities), gastro-intestinal diseases (celiac disease, enzyme disorders) and metabolic diseases
4. Prematurity less than 32 weeks
5. Congenital abnormalities, which may be relevant for this study
6. Use of systemic drugs for allergy (corticosteroids and antihistamines)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of tolerance for cow's milk, observed by a challenge test (double blind) after 12 months of treatment.

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Assessment of skin features will be performed by the objective SCORAD, as a measure for the severity of atopic dermatitis<br> 3. Need for medication<br> 4. Quality of life, as judged by the parents and noted in a questionnaire/diary<br> 5. Weight and height<br> 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<br>