Pre- and probiotics are able to change the composition of the altered intestinal microbiota that is found in allergic patients, indicating beneficial effects of these nutritional components in the prevention and treatment of allergic diseases. The…
ID
Bron
Verkorte titel
Aandoening
Atopic Eczema Dermatitis Syndrome
Ondersteuning
Wageningen, the Netherlands
Dr. A. Vriesema
(+31) 317-467800
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Decrease in Scorad score after 12 weeks of treatment is >25% greater in the active group compared to the placebo group.
Achtergrond van het onderzoek
The effect of synbiotics added to a standard infant formula will be evaluated in infants (0-7months of age) on their AEDS symptoms. Infants will receive in a double-blind fashion either standard infant formula or infant formula with added synbiotica, for 12 weeks.
Doel van het onderzoek
Pre- and probiotics are able to change the composition of the altered intestinal microbiota that is found in allergic patients, indicating beneficial effects of these nutritional components in the prevention and treatment of allergic diseases. The addition of a patented synbiotic mixture of prebiotics and probiotics to a standard infant formula is assumed to improve the clinical symptoms of AEDS.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Scorad, questionnaires on AEDS symptoms, Blood collection for safety, immunological and immunological parameters.
Stool collection for faecal microbiota evaluation.
Publiek
Alkmaar
The Netherlands
+31 317 467 800 (direct line: +31 317 467 805).
Dominique.Goossens@numico-research.nl
Wetenschappelijk
Alkmaar
The Netherlands
+31 317 467 800 (direct line: +31 317 467 805).
Dominique.Goossens@numico-research.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Main criteria:
Term infants, between 0 and 7 months of age, fulfilling standard criteria for AEDS.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Main criteria:
Scorad score < 15,
use of anti-histamines or systemic corticosteroids or anti-mycotic drugs,
Skin disorder other than AEDS.
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 | NL97 |
| NTR-old | NTR128 |
| Ander register | : N/A |
| ISRCTN | ISRCTN69085979 |