CAMEL.

Cow's milk Allergy Mediated by Elimination and Lactobacilli.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28739

Enrollment

200

Registered

2005-09-12

Start date

2003-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactJeroen Hol

Erasmus Medical Center, Sophia Children's Hospital, Department of Pediatric Pulmonology-Allergology, Room Sk-0156, Dr. Molewaterplein 60

j.hol@erasmusmc.nl+31 (0)10 4636946

Outcome results