Contact information
Type
Scientific
Primary contact
Dr Jeroen Hol
ORCID ID
Contact details
Erasmus Medical Center
Sophia Children's Hospital
Department of Pediatric Pulmonology-Allergology
Room Sk-0156
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636946
j.hol@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR339
Study information
Scientific title
CAMEL: Cow's milk Allergy Mediated by Elimination and Lactobacilli
Acronym
CAMEL
Study hypothesis
Probiotic supplementation in young infants (first 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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, double blind, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Allergy to cow's milk
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Probiotic strains (lactobacillus, bifidobacteria), Allergycare®
Primary outcome measure
Development of tolerance for cow's milk, observed by a challenge test (double blind) after 12 months of treatment.
Secondary outcome measures
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 allergenstimulated T-lymphocyte activity with specific cytokine detection
Overall trial start date
01/01/2003
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
200
Total final enrolment
119
Participant 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)
Recruitment start date
01/01/2003
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Sponsor information
Organisation
Friesland Foods (Netherlands)
Sponsor details
Blankenstein 142
Meppel
7943 PE
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18436293 (added 14/06/2019)