Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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 allergen–stimulated T-lymphocyte activity with specific cytokine detection

Overall trial start date

01/01/2003

Overall trial end date

01/01/2008

Reason abandoned

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

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

http://www.nl.frieslandcampina.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes