CAMEL: Cow's milk Allergy Mediated by Elimination and Lactobacilli
| ISRCTN | ISRCTN04799749 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04799749 |
| Secondary identifying numbers | NTR339 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jeroen Hol
Scientific
Scientific
Erasmus Medical Center
Sophia Children's Hospital
Department of Pediatric Pulmonology-Allergology
Room Sk-0156
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636946 |
|---|---|
| j.hol@erasmusmc.nl |
Study information
| Study design | Multicentre, randomised, double blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | CAMEL: Cow's milk Allergy Mediated by Elimination and Lactobacilli |
| Study acronym | CAMEL |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2003 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 119 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Friesland Foods (Netherlands)
Industry
Industry
Blankenstein 142
Meppel
7943 PE
Netherlands
| Website | http://www.nl.frieslandcampina.com/ |
|---|---|
"ROR" |
https://ror.org/025mtxh67 |
Funders
Funder type
Government
SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2008 | 14/06/2019 | Yes | No |
Editorial Notes
14/06/2019: Publication reference and total final enrolment added.
