Probiotic supplementation in young infants (1st 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…
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Development of tolerance for cow's milk, observed by a challenge test (double blind) after 12 months of treatment.
Achtergrond van het onderzoek
In a group of young children with early manifestation of allergic disease, namely cow’s milk allergy, the course of cow’s milk allergy, as well as other allergic manifestations, and the development of the immune system will be followed prospectively.
Children under the age of 6 months with cow's milk allergy will be included in this intervention study. Intervention will be performed using probiotics, double blind centrally randomised, in 50 % of the participants during a period of 12 months, which will be administered to a standard hydrolysed formula for all participants.
Doel van het onderzoek
Probiotic supplementation in young infants (1st 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.
Onderzoeksproduct en/of interventie
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 will recieve a hydrolysed formula (caseïne hydrolysate, Allergycare®, Friesland Foods).
2 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.
Algemeen / deelnemers
Dr. Molewaterplein 60
Jeroen Hol
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636946
j.hol@erasmusmc.nl
Wetenschappers
Dr. Molewaterplein 60
Jeroen Hol
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636946
j.hol@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL301 |
NTR-old | NTR339 |
Ander register | : N/A |
ISRCTN | ISRCTN04799749 |